A Study of Probiotics in IBS Subjects

NCT03482765 | Completed DMC

• 1 other identifier: UAS/170901/PB/IBS
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 12

Brief Summary

For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain. The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related quality of life, stool form and consistency and on mental status. Thus providing an effective objective in improving the gut health and symptomatic relief in IBS patients.

Conditions

IBS

Outcome Measures

Primary Outcomes (1)

• Change in abdominal pain severity

  The change at Day 42 will be assessed by subject dairy.

  42 days

Secondary Outcomes (5)

• Change in abdominal pain severity

  Day 21

• Change in IBS symptoms

  Day 42

• Change in stool consistency

  Day 42

• Change in Quality of Life

  Day 42

• Change in daily number of stools

  Day 42

Study Arms (3)

Probiotic 1

EXPERIMENTAL

Probiotic 1: A dietary probiotic supplement which contains Bifidobacterium lactis. Dose: \> 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks.

Dietary Supplement: Probiotic 1

Probiotic 2

EXPERIMENTAL

Probiotic 2: A dietary probiotic supplement which contains Lactobacillus acidophilus. Dose: \> 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks.

Dietary Supplement: Probiotic 2

Placebo

PLACEBO COMPARATOR

The Placebo contains MCC.

Other: Placebo

Interventions

Probiotic 1 DIETARY_SUPPLEMENT

The product under investigation is a unique probiotic.

Also known as: Bifidobacterium lactis

Probiotic 1

Probiotic 2 DIETARY_SUPPLEMENT

The product under investigation is a unique probiotic.

Also known as: Lactobacillus acidophilus

Probiotic 2

Placebo OTHER

Microcrystalline Cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Literate (as defined by the basic capability to read and understand in the languages approved for the study), male and female subjects in age range of 18-70 years.
• Presence of Rome IV diagnostic criteria for IBS.

You may not qualify if:

• Anemic subjects with Hb \< 10 g/dl.
• Subjects with organic disease (to be ruled out by physician based on prior history and physical examination).
• Subjects with a history of surgical resection of the stomach, small intestine or large intestine.
• Subjects with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis.
• Subjects with complications from infectious enteritis, hyperthyroidism or hypothyroidism.
• Subjects with a history of any diet-based intolerance (gluten or lactose intolerance).
• Subjects with a history of drug or alcohol abuse within the past 6 months.
• Subjects with a history of or complications from malignant tumors.
• Subjects with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).
• Subjects with uncontrolled hypertension (≥140/90 mm Hg).
• Subjects with complications from serious cardiovascular diseases, respiratory diseases, endocrinological and gynecological disorder, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.
• Subjects who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
• Subjects with a history of dysmenorrhea.
• Subjects with any unstable medical conditions.
• Subjects with uncontrolled Type II diabetes mellitus.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (12)

Apex Gastro Clinic

Ahmedabad, Gujarat, 380013, India

Location

Gastrocare & Liver Clinic

Ahmedabad, Gujarat, 380015, India

Location

The Gut Clinic

Mumbai, Maharashtra, 400012, India

Location

Vazifdar Clinic

Mumbai, Maharashtra, 400055, India

Location

Stress Test Clinic

Mumbai, Maharashtra, 400059, India

Location

Shantaee Nursing Home

Mumbai, Maharashtra, 400067, India

Location

Dr Sanjeev Khanna's Clinic

Mumbai, Maharashtra, 400069, India

Location

Ameeta Nursing home

Mumbai, Maharashtra, 400071, India

Location

Lancelot Kidney and GI Center

Mumbai, Maharashtra, 400092, India

Location

Kshirsagar Nursing Home

Mumbai, Maharashtra, 400602, India

Location

Samarth Clinic

Navi Mumbai, Maharashtra, 400703, India

Location

Sampada Hospital

Thane, Maharashtra, 400601, India

Location

MeSH Terms

Interventions

Lacteol

Study Officials

• Shalini Srivastava, M.D.

  Vedic Lifesciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Apart from the participant and Investigator, the study team is also blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 29, 2018
• Study Start: March 30, 2018
• Primary Completion: March 14, 2019
• Study Completion: June 30, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

IN (12)