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Evaluation of Safety and Efficacy of Dietary Supplement ZyGluten In Patients with Gluten Sensitivity

Journal of Gluten Sensitivity Winter Issue - Originally published January 14, 2015


Image: CC--Health Gauge

Celiac.com 07/05/2016 - Principal Investigator: Amrit P.S. Narula M.D, F.A.C.P, F.A.C.G, F.A.C.N., A.G.A.F
Study Coordinator: Alicia Mercuri, PA-C

Background
Research estimates that approximately 18 million Americans have gluten sensitivity. That is six times more than patients confirmed with celiac disease. Non-celiac gluten sensitivity is defined as those individuals who cannot tolerate gluten in the diet and experience the same symptoms attributed to celiac disease, but lack antibodies and intestinal damage as seen in celiac disease.

A dietary supplement called ZyGluten was developed from in vitro studies, not in vivo. The primary aim in its development was a supplement which, if taken at the beginning of a meal, would hydrolyze gluten concentration in ingested food. Foods tested included McDonald's hamburger, white sliced bread, a plain bagel, macaroni and cheese, spaghetti, a muffin, and frozen pizza. The amount of gluten was measured at 0, 30 and 60 minutes after the introduction of ZyGluten. In all samples, gluten measured at the end of 60 minutes was less than 20 ppm.

ZyGluten is a compound of amylases, proteases, and lipase enzymes with probiotics, specifically Lactococcus lactis and Lactococcus cremoris. It is derived from plant and microbial sources.

Inclusion Criteria

  • Ages 18-80 years
  • Physician diagnosed gluten sensitivity by history and experienced symptoms of gluten sensitivity for at least 1 month prior to involvement
  • Willing to take supplement twice daily for 2 weeks
  • Sign informed consent

Exclusion criteria

  • Active Inflammatory Disease
  • Celiac disease confirmed by antibodies and duodenal biopsy
  • Peptic ulcer disease
  • Lactose intolerance
  • Pregnant or lactating women
  • Received any experimental drug within 30 days of enrollment

Methods
27 patients, all of whom met the inclusion criteria, were selected to take 2 capsules of ZyGlutens before 2 major meals of the day for 2 weeks. 23 patients were female and 4 were male, with ages ranging from 25-77. The following symptoms were assessed at baseline, week 1, and week 2 which was the conclusion of the study:

  • Abdominal pain
  • Diarrhea
  • Constipation
  • Headaches
  • Joint pain
  • Fatigue
  • The severity of symptoms was measured as mild, moderate, or severe, and none if symptoms were absent.

All patients were contacted by phone within 48 hours of start of the trial to assess for any adverse effects. Following parameters were checked at baseline, week 1, and week 2:

  • Weight
  • Height
  • Blood pressure
  • Pulse rate
  • Respiration rate
  • Patients were not charged or reimbursed for their participation in the study.

Results
The following number of patients (27) had these symptoms at baseline:

 

None

Mild

Moderate

Severe

Abdominal Pain/Cramping

1

1

16

9

Bloating/Distention

0

3

9

15

Diarrhea

10

4

2

11

Constipation

16

2

3

6

Headaches

11

5

7

4

Joint Pains

12

2

9

4

Fatigue

3

4

5

15

 The following number of patients (23) had these symptoms at week 1:

 

None

Mild

Moderate

Severe

Abdominal pain/Cramping

10

7

4

2

Bloating/Distention

9

10

1

3

Diarrhea

16

5

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2

0

Constipation

20

1

1

1

Headaches

17

2

3

1

Joint Pains

14

2

4

3

Fatigue

7

8

3

5

The following number of patients (23) had these symptoms at week 2: 

 

None

Mild

Moderate

Severe

Abdominal Pain/Cramping

15

4

2

2

Bloating/Distention

14

6

1

2

Diarrhea

21

1

1

0

Constipation

21

1

0

1

Headaches

16

5

1

1

Joint Pains

17

3

2

1

Fatigue

10

7

1

5

The following number of patients rated their symptom improvement as:

  • No improvement: 0
  • Improved: 4
  • Markedly improved: 19

Adverse Effects
No patients reported any adverse effects.

Participants
Twenty-seven participants were enrolled in the study. Two patients withdrew from the study; one of which had a scheduling conflict with follow-up visits and one stopped taking the medication due to increased sleepiness after two pills. Two patients were lost to follow-up. These four patients were excluded from analysis.

Conclusion
In conclusion, ZyGluten study is a 2 week open labeled trial. Our outcome so far has shown to be extremely efficacious with no significant side effects. There was no significant difference found in patients who complained of headaches or joint pain. The majority of the patients found significant improvement in their symptoms of abdominal pain, bloating, changes in bowel habits, and fatigue. In fact, 83% of patients rated that their symptoms markedly improved, and 17% rated an improvement in their symptoms.

Patient Testimonials

  • *The medication was known by patients as ‘Gluten Buster' during the clinical trial.
  • "Medication has given me more freedom. I am no longer afraid to eat, especially away from home. I am very pleased with the medication".-MF
  • "My symptoms have improved. I would like to keep taking this if I can, especially since it's natural, to see how long I can go without an endoscopy".-MH
  • "I feel that this pill has made a tremendous improvement in my condition". –BW
  • "Bloating is gone. Stools seem to be more formed. Feeling good". –PS
  • "It's wonderful to not be limited in what I can eat. It's great not to have the symptoms of pain, etc. when eating gluten foods". –JH
  • "Great for bloating".-JF
  • "Very little of passing gas. I feel good". -PW
  • "Bloating is a lot better". -LW
  • "I have not had any cramping or urgency to have a BM after a meal. My bowel movements are now normal. I have had no GI distress since on the meds". –KY
  • "Gluten Buster has been a miracle pill. After so many years of having bowel problems, I never knew what it was like to have a regular bowel movement. I have had no problems with digestive system since I starting taking these pills". -JM
  • "Medication was very helpful". –KO
  • "My experience with the Gluten Buster that Dr. Narula has given me to take has been simply amazing. It has made my quality of life so much better. He is an amazing doctor to help those that otherwise thought there was no hope! I feel great"!-CM
  • "Seems a little bit better. Still have IBS. Still have a lot of gas and bloating."-AM
  • "It has been helping to go to the bathroom. The weight is going up and the stomach is going down a little bit".-SH
  • "Before taking the medicine, mornings were hard because of bloating and diarrhea. Now I feel great in the morning".-GK
  • "Gluten Buster is a life changer. Will definitely go on it when available in market." -MC
  • "It is helping with bloating and gas. Has improved all of my GI symptoms. Overall, I can eat anything, including French fries and food I could not eat before (Super Pill)". -MK
  • "I feel it has improved. Still have bloating, but eating regular food. Diarrhea has improved, no pain in stomach or abdomen". -BS
  • "I feel 10x better than I did before starting the medication. No stomach cramps of bloating, I only have a BM twice/day. Feel great!" -JB
  • "I am doing 100% better now since I have been taking the Gluten Buster meds". - JZ
  • "Passing more gas, feeling better". -ML
  • "I'm feeling better. I'm eating anything I want, not sticking with gluten free food. If it's due to taking the Gluten Buster, then I would still take it". -BS
  • "It has made a big difference in bloating and abdominal pain. I would like to continue taking it". -JP
  • "My stomach feels fantastic when I take the product. This should be available for all people with gluten sensitivity. This would be a great idea for Shark Tank. It needs to be available to the masses! I don't know how my stomach will survive without it, especially at the holidays". -LT

References

  1. Am J Gastroenterol. 2011 Mar;106(3):508-14; quiz 515. doi: 10.1038/ajg.2010.487. Epub 2011 Jan 11. Gluten causes gastrointestinal symptoms in subjects without celiac disease: a double-blind randomized placebo-controlled trial. Biesiekierski JR1, Newnham ED, Irving PM, Barrett JS, Haines M, Doecke JD, Shepherd SJ, Muir JG, Gibson PR.
  2. The Oslo definitions for celiac disease and related terms. Jonas F Ludvigsson,1,2 Daniel A Leffler,3 Julio C Bai,4 Federico Biagi,5 Alessio Fasano,6 Peter H R Green,7 Marios Hadjivassiliou,8 Katri Kaukinen,9 Ciaran P Kelly,3 Jonathan N Leonard,10 Knut Erik Aslaksen Lundin,11 Joseph A Murray,12 David S Sanders,13,14 Marjorie M Walker,14 Fabiana Zingone,15 Carolina Ciacci16
  3. Food Allergy - An Overview (PDF|1 MB). DHHS. NIH. National Institute of Allergy and Infectious Diseases.
  4. Gastroenterol Hepatol. 2014 Jun-Jul;37(6):362-71. doi: 10.1016/j.gastrohep.2014.01.005. Epub 2014 Mar 22. [Non-celiac gluten sensitivity: a critical review of current evidence]. [Article in Spanish] Molina-Infante J1, Santolaria S2, Montoro M2, Esteve M3, Fernández-Bañares F3.
  5. Gluten Causes Gastrointestinal Symptoms in Subjects Without Celiac Disease: A Double-Blind Randomized Placebo-Controlled Trial. Jessica R Biesiekierski, Evan D Newnham, Peter M Irving, Jacqueline S Barrett, Melissa Haines, James D Doecke, Susan J Shepherd, Jane G Muir and Peter R Gibson.
  6. Nutrients. 2013 Sep 26;5(10):3839-53. doi: 10.3390/nu5103839. Non-Celiac Gluten sensitivity: the new frontier of gluten related disorders. Catassi C1, Bai JC, Bonaz B, Bouma G, Calabrò A, Carroccio A, Castillejo G, Ciacci C, Cristofori F, Dolinsek J, Francavilla R, Elli L, Green P, Holtmeier W, Koehler P, Koletzko S, Meinhold C, Sanders D, Schumann M, Schuppan D, Ullrich R, Vécsei A, Volta U, Zevallos V, Sapone A, Fasano A.
  7. BMC Med. 2014 May 23;12:86. doi: 10.1186/1741-7015-12-86. Non-celiac gluten sensitivity - why worry? Lundin KE.
  8. BMC Med. 2014 May 23;12:85. doi: 10.1186/1741-7015-12-85. An Italian prospective multicenter survey on patients suspected of having non-celiac gluten sensitivity. Volta U1, Bardella MT, Calabrò
  9. Neurogastroenterol Motil. 2013 Nov;25(11):864-71. doi: 10.1111/nmo.12216. Epub 2013 Aug 12. Non-celiac gluten sensitivity: clinical relevance and recommendations for future research. Mooney PD1, Aziz I, Sanders DS.
  10. World J Gastroenterol. 2014 Jul 21;20(27):8837-45. doi: 10.3748/wjg.v20.i27.8837. Irritable bowel syndrome and food interaction. Cuomo R, Andreozzi P, Zito FP, Passananti V, De Carlo G, Sarnelli G.
  11. Expert Rev Gastroenterol Hepatol. 2012;6(1):43-55. Problems of an Emerging Condition Separate From Celiac Disease. Amy C Brown
  12. Dig Dis Sci. 1999 Jul;44(7):1317-21. Pancreatic supplements reduce symptomatic response of healthy subjects to a high fat meal. Suarez F1, Levitt MD, Adshead J, Barkin JS.

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1 Response:

 
ANNA
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
11 Jul 2016 2:47:02 PM PDT
WILL THIS BE ON THE MARKET SOON ? I WOULD LOVE TO TRY IT.




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Cycling Lady, LMAO at IBeStumped! So true. Yes, he is trying the band aid approach it seems. That's probably the most frustrating thing of all. So yesterday I get a call back from his office and they say to stop taking the Viberzi and switch back to Imodium! I reminded them that Imodium didn't work, I had already used it 8 days with no changes. His assistant informed me that that is all he can recommend at this time until he sees me at my next appointment which is 5/24! I live near Chicago and I am about to make an appointment to go to the University of Chicago hospital which is the top celiac research hospital in the country. Hopefully they can give me better answers.

7Hi jen and welcome No-one can diagnose remotely via nterwe posts but if there was such a game as celiac / gluten sensitive bingo, I would be calling 'House!' having read your account above... Lots of things fit the pattern as I'm sure your lurking has revealed. It's a tricky condition to diagnose however so you may have a little wait before you join the coolest club in town and get your funky celiac membership card For now it's really important that you stay on gluten. Keep eating it as accurate testing requires it. Ask your doctor to check the boxes for celiac testing alongside your liver blood tests. There should be enough in your history to get this without hassle but if they're reluctant INSIST and don't be afraid to assert your reasonable suspicion and wish to clarify and exclude. A good liver specialis will be aware of the possible links so you should be ok. If not gt second opinion. Ask for a full celiac panel as there are variety of tests. Find further info here There's a lot to take in, but be positive, I think you are on the right track and if so, you could soon be feeling better than you ever thought possible!

Hello, I am in a job that I travel every 3rd week...It gets challenging becuase many times I am doing audits of warehouses and they dont even have a cafeteria. I usually bring gluten-free protein bars as a back up if I have to miss a meal and then eat when I get back to the hotel. Just a suggestion because they certainly fill me up....Have a safe trip...Kelly

Hello all, I'm a new member here but have lurked for a while. I'm looking for some advice regarding my medical history, possible symptoms of celiac and next steps. General info: female, low level smoker, drink alcohol, aged 32. I started having bad gastro issues when I was around 17. Since then I've consistently suffered from chronic diarrhoea, frequent discomfort in the tummy area, feelings of dehydration despite drinking at least eight glasses a day and frequent fatigue for no real reason. In 2008/9 I visited the doctor as my diarrhoea was having an effect on my studies at the time. The doctor tested me for allergies; eggs, fish, gluten and lactose and did a "standard" blood test. Everything came back fine except my liver results, which were elevated to double (I did not the see the results for myself so can't say which enzymes etc). I was told to drink less and take Imodium. The doctor implied that perhaps I was stressed and / or anxious and, still being young plus a student who regularly went out drinking, I accepted this advice and carried on with my life. I would here add that I am not an unusually stressed person - in fact, learning to deal with my unpredictable bowels has forced me to be quite a laid-back person! Fast forward to 2016. I had been living with my partner for two years by this point who had noticed my bowel habits and informed me that this was definitely not normal. He encouraged me to try out a gluten free diet since I was apprehensive about visiting a doctor only to be fobbed off with Imodium again. I did the diet as strictly as a newbie can for around two months before we set off travelling. During the diet I noticed that after a couple of weeks of extreme tiredness I felt quite a lot better - I kept a food journal at the time which showed that I almost immediately had diarrhoea once after eating an ice-cream, i felt bloated and unwell after an attempt to make oat muffins (maybe i didn't cook them very well though!) and I felt bloated and had diarrhoea after eating some fish fried in flour (We made a mistake in ordering them but I didn't want to complain). My partner also reported that my mood swings (which I admit can be a little unpredictable) were much better. Once we started travelling I gave up and ate what I was given as we were staying with friends etc much of the time. Toward the end of our trip I started to feel extremely tired, to the point of having to stay in for "rest" days, and my guts were very unhappy. I chalked it up to irregular eating patterns, too many beers and late nights in general. During the trip I also had an extreme hangover after drinking wheat beer. And, while of course I accept that any overindulgence can make you ill, I really felt that that level of hangover was quite out of the ordinary. Finally, I developed a strange lump under my armpit during this period. Now back at home, I decided to go to the doc and check out the odd lump under my armpit. The doctor was pretty confident that it was nothing to worry about cancer-wise but she ordered a battery of blood tests just to be sure. The lump is fine (good news) but the results showed elevated GGT, high-ish ALT and normal AST liver enzymes plus signs of dehydration in red bloods / higher (but not concerning) levels of white bloods. I'm scheduled to go back for another blood test to double-check liver function and discuss results - if it is again high she will send me for a ultrasound. Does this history chime with anyone here? I know that the correct course in basic health terms is to stop drinking for some time (easily done) and stop smoking forever (easy to say...) but I cannot help but think that something else is going on here. I will discuss this with my doctor and make clear that my bowel issues have not been resolved and that the initial IBS diagnosis wasn't based on any thorough testing so to speak. In the meantime - does anyone have any advice for me in times of avenues to research or experience of similar symptoms? Gluten remains in my diet but in all other respects it could be regarded as very healthy, I think anyway... (pescatarian, plenty of fruit and veg, little to no sugar on a daily basis, not much dairy to speak of...) Thanks in advance and sorry for bending everyone's' ear about this... I guess it's just taken a long time for me to admit I might be sick and I need some help. Jen

Wish I could give you a hug. Unfortunately I know how that feels with Neurologists, Internists, Endocrinologists, Rheumatologists, GIs..... I got so tired of crying my drive home after refusing yet another script for Prozac. I do hope your GI can give you some answers even if it is just to rule out other possible issues. Keep on the gluten and we are here for you.