Clinical trial NCT03482765: A Study of Probiotics in IBS Subjects
Official title: A Double-blind Randomized, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Probiotics (UABla-12™ and DDS®-1) on Digestive Health in IBS Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study aims to determine the effect of probiotics, as the investigational products (IPs) in subjects satisfying the Rome IV criteria for IBS. Three hundred and sixty six subjects between 18 to 70 years of age and with a positive diagnosis of Rome IV IBS criteria (IBS-C, D, M and U types) and moderate to severe abdominal pain intensity will be recruited in a multi-center, double-blind, parallel group, placebo-controlled randomized trial.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Subjects with a history of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.
* Subjects who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis).
* Subjects with any medical condition or a history of abdominal surgery that is deemed exclusionary by the qualified investigator.
* Subjects with an active eating disorder.
* Subjects who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.
* Subjects who have used probiotic or fiber supplements (or probiotic/fiber enriched foods) or an antibiotic within 4 weeks prior to screening.
* Subjects who have used IBS specific treatments within 4 weeks prior to screening.
* Subjects who currently consume greater than 2 standard alcoholic drinks per day from past 3 months.
* Subjects who smoke ≥ 1 cigarette per day. Occasional (Non-daily) smokers will be allowed.
* Subjects who have participated in a clinical research trial within 30 days prior to randomization.
* Subjects with an allergy or sensitivity to the probiotic products.
* Subjects who are cognitively impaired and/or who are unable to give an informed consent.
* Subjects who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the qualified investigator, may adversely affect the subjects' ability to complete the study or its measures or which may pose significant risk to the subject.

Primary outcomes:
measure: Change in abdominal pain severity
timeFrame: 42 days
Secondary outcomes:
measure: Change in abdominal pain severity
timeFrame: Day 21
measure: Change in IBS symptoms
timeFrame: Day 42
measure: Change in stool consistency
timeFrame: Day 42
measure: Change in Quality of Life
timeFrame: Day 42
measure: Change in daily number of stools
timeFrame: Day 42
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Apex Gastro Clinic
state: Gujrat
city: Ahmedabad
country: India
facility: Gastrocare & Liver Clinic
state: Gujrat
city: Mumbai
country: India
facility: The Gut Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Vazifdar Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Stress Test Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Shantaee Nursing Home
state: Maharashtra
city: Mumbai
country: India
facility: Dr Sanjeev Khanna's Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Ameeta Nursing home
state: Maharashtra
city: Mumbai
country: India
facility: Lancelot Kidney and GI Center
state: Maharashtra
city: Mumbai
country: India
facility: Kshirsagar Nursing Home
state: Maharashtra
city: Navi Mumbai
country: India
facility: Samarth Clinic
state: Maharashtra
city: Thāne
country: India
facility: Sampada Hospital
state: Maharashtra
Study officials:
affiliation: Vedic Lifesciences
name: Shalini Srivastava, M.D.
role: STUDY_DIRECTOR
References: