Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this Phase II trial is to test the NTX-1 Fiber in patients with constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially modify gut microbiota composition, and improve gut milieu in these patients. The investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e has less side effects) and is more effective than psyllium (the most commonly used fiber in the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in those with dysbiosis and low SCFA levels.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nutrabiotix, LLC
• Collaborator: Rush University Medical Center
• Treatments: Calcium polycarbophil; Psyllium

Criteria

Inclusion - History

1. Between the ages of 18-75

2. Have recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months

3. Have at least 2 of the following in the last 6 months:

1. Improvement of abdominal pain or discomfort with defecation

2. Onset of abdominal pain or discomfort associated with change in frequency of stool

3. Onset of abdominal pain or discomfort associated with a change in form/appearance of stool

4. Symptom onset at least 6 months prior to screening date

5. Willing to take study supplement three times a day and willing to comply with all study procedures (i.e. swallow capsules)

6. Willing to stop taking over-the-counter laxatives after the 2 week screening period (Ex: ex-lax, senna, miralax, milk of magnesia)

Inclusion - Screening Diary

7. Abdominal bloating/discomfort/pain (if either a, b, OR c is positive, then this meets the criteria for #7)

1. A weekly average of worst abdominal bloating score of ≥ 3 during the screening period on a 0-10 numeric rating scale

2. A weekly average of worst abdominal discomfort score of ≥ 3 during the screening period on a 0-10 numeric rating scale

3. A weekly average of worst abdominal pain score of ≥ 3 during the screening period on a 0-10 numeric rating scale

8. Bowel movements/stool consistency (if either a OR b is positive, then this meets the criteria for #8)

1. Less than 3 spontaneous complete BM (SCBM) per week. (SCBM is defined as a BM occurring in the absence of a laxative that is associated with a sense of complete evacuation)

2. Stool consistency of 1-2 on Bristol scale at least twice a week OR >25% of BM for the week

Exclusion- Lab Results

1. Abnormalities in CBC (Hgb<12 g/dL, platelet count<100000, WBC<4000 or >10000)

2. Abnormal liver function tests (ALT, AST, alkaline phosphatase, or bilirubin >1.5 times normal range)

3. Abnormal renal function tests (BUN or creatinine >1.5 times normal range)

4. Low serum albumin (<3 g/dL)

5. Uncontrolled thyroid disease as evident from abnormal TSH level

6. High CRP (> 5), except those evaluated for IBD and IBD is ruled out through colonoscopy, CT or additional tests

7. Insulin-requiring and/or poorly controlled diabetes (well-controlled diabetics with HbA1c <7 may be enrolled)

Exclusion- History

8. Patient history of GI diseases (except for hemorrhoids or occasional (<3 times a week) heartburn)

1. Inflammatory bowel disease (Ex: ulcerative colitis, crohn's disease, any colitis)

2. Celiac disease

3. Colonic inertia (lazy/slow colon resulting in surgery, resection or daily laxatives)

4. Diverticular stricture (narrowing of the colon)

9. Antibiotic use within last 4 weeks

10. Severe uncontrolled hypertension

11. Significant uncompensated cardiac or respiratory diseases (defined as requiring daily medication for management of their diseases (Ex: on oxygen or can't walk))

12. Prior extensive intestinal resection

13. History of psychiatric hospitalization OR suicide attempt in the last 5 years

14. Drug and/or alcohol abuse

15. Plan to have a major change of their dietary habit during the following 5 months

16. Drug induced constipation (Ex: opiates)

17. Pregnant or lactating

18. Use of narcotic medications (pain killers, Ex: hydrocodone, methadone, morphine, oxycodone or tramadol) or anticoagulant/antiplatelet agents (ex: heparin, warfarin , dabigitran., Coumadin)

19. If the subject is older than 50 years of age, subjects who have not had a colonoscopy within last 7 years or CT colonography within last 5 years to rule out colon cancer

20. Alarm symptoms of colon cancer such as:

1. Weight loss (>10% unintentional loss of body weight in last 6 months)

2. Blood in the stool (except for clearly documented hemorrhoidal bleed OR colonoscopy excluding colon cancer within the last year for blood in the stool)

3. Anemia (without a full work-up, including a colonoscopy or other tests deemed important)

21. Continued chronic and daily use of prescription laxatives (Ex: Amitiza or Linzess/ linaclotide in the last month)

22. Loose or watery stools > than 3 times per week

23. History of fecal impaction requiring disimpaction in the last 3 months

24. History of laxative abuse (Ex: eating disorders)

25. Use of medications that affect gastrointestinal motility (i.e. resolor, domperidone, reglan, cisapride, anticolonergic drugs, tricyclic antidepressant [Ex: Amitriptyline, Amoxapine, anafranil, asendin, elavil, norpramin/desipramine, doxepin, pamelor/nortriptyline, sinequan, surmontil/trimipramine, tofranil/imipramine or vivactil/protriptyline]) SSRI's are OK

26. Documented untreated pelvic floor dysfunction

27. Colonic organic diseases such as:

1. Current colonic cancer or strictures

2. Connective tissue disease (ex: scleroderma, lupus)

3. Other neurological disorders leading to chronic constipation (Ex: Parkinson's or multiple sclerosis)

28. Dietary intake exceptionally high in plant-based, high fiber foods, including those following a strict vegetarian diet (high fiber foods: fruits, vegetables, beans, whole grains, fortified foods)

29. Consumption of probiotics, prebiotics, or synbiotics without an appropriate 2-week washout period (Ex: Activia, FiberOne products, probiotics supplements such as Align, Pearls, or fiber/prebiotic supplements such as Metamucil, Benefiber, Citrucel, Fiber Choice, Fiber Powder)

30. Intention of using fiber products during the study (other than the study supplement)

31. Known food allergies or hypersensitivities (Ex: the components of psyllium or NTX-1 (corn))

32. Have a colonoscopy done within the next 5 months

Exclusion- Screening Diary 32. Use of laxatives more than twice in the screening period (The following are the ONLY laxatives the subject is allowed to use during the screening period: Ex-lax, senna, miralax and milk of magnesia) 33. Have not completed 11 out of 14 days of symptoms diary at screening 34. Have an average daily IBS-C global symptom score of <2 in the screening period 35. Average Bristol stool scale of more than 4 within the screening period 36. Loose or watery stools with Bristol stool scale of 5 or greater for a total of 6 or more days during the screening period 37. Use of fiber products during the screening period