To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome

NCT04950296 | Completed

• 1 other identifier: UAS201003/LPLANTARUMUALP05IBS
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 12

Brief Summary

Several probiotic strains have shown beneficial outcomes in IBS patients, particularly among the Lactobacillus and Bifidobacterium genera, Lactobacillus plantarum (recently reclassified as Lactiplantibacillus plantarum) is a frequently isolated species of the healthy human GI tract that has been studied in numerous GI clinical studies, including for IBS.In the present study, the efficacy and tolerability of L. plantarum (UALp-05TM), will be evaluated in individuals with IBS-D.

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (1)

• Irritable Bowel Syndrome Symptom Severity Scale

  To evaluate the effect of IP consumption on change in Irritable Bowel Syndrome Symptom Severity Scale total score on day 56 from baseline (Day 0) in comparison to placebo. A score on a scale, include 0 to 100 pointer scale the minimum score is the better outcome and maximum values is worse outcome.

  Day 0, Day 56

Secondary Outcomes (5)

• Irritable Bowel Syndrome Symptom Severity Scale

  Day 28

• Abdominal Pain Severity Numeric Rating Scale

  Screening, Day 0, Day 28 and Day 56

• Bristol Stool Scale

  Screening, Day 0, Day 28 and Day 56

• Irritable Bowel Syndrome Symptom Severity Scale percent responder

  Day 56

• Irritable Bowel Syndrome -Quality of Life

  Day 0, Day 28 and Day 56

Study Arms (3)

Group I: L. plantarum UALp-05TM,

ACTIVE COMPARATOR

One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.

Other: Group I: L. plantarum UALp-05TM,

Group II: L. plantarum UALp-05TM,

ACTIVE COMPARATOR

One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.

Other: Group II: L. plantarum UALp-05TM,

Microcrystalline Cellulose

PLACEBO COMPARATOR

One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.

Other: Microcrystalline cellulose

Interventions

Group I: L. plantarum UALp-05TM, OTHER

One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.

Also known as: Active

Group I: L. plantarum UALp-05TM,

Group II: L. plantarum UALp-05TM, OTHER

One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.

Also known as: Active

Group II: L. plantarum UALp-05TM,

Microcrystalline cellulose OTHER

One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.

Also known as: Placebo

Microcrystalline Cellulose

Eligibility Criteria

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

You may qualify if:

• Males and females aged 18 to 70 years.
• Participants with Irritable bowel syndrome (IBS) as per Rome IV IBS criteria:
• Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
• Related to defecation (Maybe increased or decreased by defecation)
• Associated with a change in the frequency of stool (increase in frequency)
• Associated with a change in the form (appearance) of stool
• History of abnormal bowel movements, which are predominantly diarrhea (more than one-fourth (25%) of bowel movements with BSS Types 6-7 and less than one-fourth (25%) with BSS Types 1-2) in the last one month prior to screening.
• Average APS-NRS score of ≥ 6 for last 3 months prior to screening visit.
• Fasting blood glucose levels ≤ 125 mg/dL (6.94 mmol/l).
• Hemoglobin ≥ 10 g/dL.
• Able to comply and perform the procedures requested by the protocol (consumption of study medications, filling scheduled eDiary for health updates, biological sample collection procedures and study visit schedule).
• Participants with access to western toilet facilities.
• Participants with non-vegetarian dietary preferences (Note: Non-vegetarian food will be defined as food derived from animals, birds, fish, shell-fish, etc)
• Participants consuming non-vegetarian food for at least 2 times in a week.
• SpO2 ≥ 96% as assessed by fingertip pulse oximetry

You may not qualify if:

• Participants not meeting IBS-D diagnostic criteria (i.e. IBS-Constipation, Mixed or Unclassified).
• Uncontrolled abnormal Thyroid Stimulating Hormone (TSH) value which is \< 0.35 or \> 4.94 μIU/mL.
• Uncontrolled Type II DM (Controlled Type II diabetics can be included upon investigator's discretion).
• Type I diabetes.
• Uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg.
• Use of probiotics and/or prebiotics (In the form of supplements) within the last 4 weeks prior to screening.
• Use of medicines (Prescription, OTC, etc), health supplements or herbal medicines expected to promote gut health and alleviate IBS related complications within the last four 4 months prior to screening.
• Established diagnosis of Helicobacter pylori infection in last 3 months prior to screening.
• History of surgical resection of the stomach, small intestine or large intestine.
• Participants with acute gastroenteritis.
• History or complications of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or ischemic colitis.
• Participants with complications from infectious enteritis.
• History of any diet-based intolerance (gluten or lactose intolerance).
• History of or complications from malignant tumors.
• History of any significant neurological or psychiatric condition which may affect study participation or inference of study outcomes.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (12)

Apex Gastro Clinic and Hospital,

Ahmedabad, Gujarat, 380013., India

Location

SN Gastro and Liver Clinic

Ahmedabad, Gujarat, 380054, India

Location

Ahmedabad Gastro Associates,

Ahmedabad, Gujarat, 380061, India

Location

Aman Hospital and research center

Vadodara, Gujarat, -390021., India

Location

My Health Clinic,

Mumbai, Maharashtra, 400059., India

Location

Dr. Khanna Clinic,

Mumbai, Maharashtra, 400059, India

Location

Stress Test Clinic

Mumbai, Maharashtra, 400059, India

Location

Samarth Digestive Disease Centre

Mumbai, Maharashtra, 400705,, India

Location

Rahate Surgical Hospital,

Nagpur, Maharashtra, 440008., India

Location

Ashirwad Hospital And Research Centre,

Ulhasnagar, Maharashtra, 421004, India

Location

Shubham Sudbhawana Superspeciality Hospital,

Varanasi, Uttar Pradesh, 221005., India

Location

Khannas Clinic

Varanasi, Uttar Pradesh, 221010, India

Location

MeSH Terms

Interventions

Exercise; microcrystalline cellulose

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr. Ramesh Dargad

  Stress test clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled, parallel group

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 6, 2021
• Study Start: September 16, 2021
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-01

Locations

IN (12)