A Study of Probiotics in IBS Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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IBS

Intervention / Treatment
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* Dietary Supplement: Probiotic 1
* Dietary Supplement: Probiotic 2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic 1<br>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<br>* The product under investigation is a unique probiotic.<br>* Other names: Bifidobacterium lactis;|
| Experimental: Probiotic 2<br>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<br>* The product under investigation is a unique probiotic.<br>* Other names: Lactobacillus acidophilus;|
| Placebo Comparator: Placebo<br>The Placebo contains MCC. | Other: Placebo<br>* Microcrystalline Cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal pain severity | The change at Day 42 will be assessed by subject dairy. | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal pain severity | The change at Day 21 will be assessed by subject dairy | Day 21 | 
| Change in IBS symptoms | The change at Day 42 will be compared to baseline | Day 42 | 
| Change in stool consistency | The change at Day 42 will be compared to baseline by specific questionnaire | Day 42 | 
| Change in Quality of Life | The change at Day 42 will be compared to baseline by specific questionnaire | Day 42 | 
| Change in daily number of stools | The change at Day 42 will be compared to baseline | Day 42 |