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

NCT02144753 | Terminated Phase 2 DMC

• 1 other identifier: SBIR-2013-NTX
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation-predominant IBS (IBS-C)

Keywords

IBS-C; Constipation; IBS

Outcome Measures

Primary Outcomes (1)

• Composite improvement in the following three areas: IBS global improvement score on the Likert Scale, frequency & consistency of stools, & severity of abdominal pain, discomfort and bloating

  Compare the effects of NTX-1 (18 grams) against psyllium (15 grams) on IBS global improvement score, frequency \& consistency of stools, \& severity of abdominal pain, discomfort and bloating in patients with IBS-C (as defined by the Rome III criteria).

  up to 14 months

Secondary Outcomes (1)

• Determine side effects of NTX-1

  up to 14 months

Study Arms (2)

NTX-1

EXPERIMENTAL

NTX-1 (18 g)

Dietary Supplement: NTX-1

Psyllium

ACTIVE COMPARATOR

psyllium (15 g)

Drug: psyllium (15 g)

Interventions

NTX-1 DIETARY_SUPPLEMENT

Investigational NTX-1 fiber to be taken as three (6g each) packets of the fiber per day, one 8g packet in the morning (one hour before eating breakfast) and the other two 8g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.

Also known as: Nutrabiotix (18g)

NTX-1

psyllium (15 g) DRUG

Psyllium (an over-the-counter fiber) to be taken as three (5g each) packets of the fiber per day, one 5g packet in the morning (one hour before eating breakfast) and the other two 5g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.

Also known as: psyllium

Psyllium

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nutrabiotix, LLC: lead
• Rush University Medical Center: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Ece Mutlu, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 22, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

US (1)