Probiotic in Irritable Bowel Syndrome (IBS) Patients With Diarrhea

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01667627
• Date of registration: 15/08/2012
• Prospective Registration: Yes
• Primary sponsor: Tel-Aviv Sourasky Medical Center
• Public title: Probiotic in Irritable Bowel Syndrome (IBS) Patients With Diarrhea IBS-D
• Scientific title: A Double-blind, Placebo-controlled Study to Assess the Effect of Probiotic on Symptom Relief and Indices of Micro-inflammation and Cholinergic Status in IBS Patients With Diarrhea.
• Date of first enrolment: January 2014
• Target sample size: 107
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01667627
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Israel

Contacts

• Name: Ami Sperber, MD
• Affiliation: Tel Aviv Medical Center

• Name: Roy Dekel, MD
• Affiliation: Tel Aviv Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

A diagnosis of IBS-D according to the Rome III criteria, agreement to participate and the
ability to sign an informed consent. Moreover, the definition of inclusion criteria is
based on the FDA Draft Guidance for Clinical Evaluation of Products (add ref here). Over
the two week run-in period:

- Pain Intensity: weekly average of worst abdominal pain in past 24 hours score of = 3.0
on a 0 (no pain at all) to 10 (worst possible pain) point scale

- Stool Consistency: =30% of days/week with at least one stool =6 using the Bristol
Stool Score (BSS, Fig. 1) (ref).

Exclusion Criteria:

1) Hyperthyroidism, 2) celiac disease 3) pregnancy, 4) other gastrointestinal diagnoses
that might interfere with the study (e.g. active peptic disease, inflammatory bowel
disease), 5) a history of malignancy that might, to the best judgment of the doctor,
interfere with the study, 6) any infectious or inflammatory disease within the last month,
7) active medically treated asthma, 8) baseline levels of HsCRP > 10mg/liter, 9) steroid
treatment for any indication, 10) fecal incontinence, and 11) treatment with probiotics or
antibiotics of any kind within the last 4 weeks, 11) Diabetes.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

IBS

Intervention(s)

Dietary Supplement: Bio-25

Other: Placebo

Primary Outcome(s)

Symptom relief (abdominal pain and stool consistency) [Time Frame: 8 weeks]

Secondary Outcome(s)

Improvement in other specific IBS symptoms, i.e., gas and bloating, feeling of urgency [Time Frame: 8 weeks]

Reduce hs-CRP levels [Time Frame: 8 weeks]

Reduce calprotectin levels [Time Frame: 8 weeks]

Improve the cholinergic status [Time Frame: 8 weeks]

Secondary ID(s)

TASMC-11-RD-0491-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors