A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of Two Different Mixes of HMO-2FL + Humiome® Post LB Postbiotic (Postbiotic-LB) on Gastrointestinal Symptoms in Irritable Bowel Syndrome (IBS) Subjects

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2'-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Written and signed informed consent (will be obtained before any study-related Assessments).

• Male or female aged ≥18 - 70 years at the time of consent.

• Female individuals of childbearing potential (Females who are peri or post-menopausal, i.e., when there has been no or irregular menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential.), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until:

‣ Sexual abstinence.

⁃ Oral contraceptives.

⁃ Trans-dermal patches or depot

⁃ injection of a progestogen drug (starting at least 4 weeks prior to product administration).

⁃ Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent.

⁃ Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration/2 weeks prior screening).

⁃ Contraceptives must be effective before the randomization visit.

• Individuals with plasma FBG (fasting blood glucose) (less than equal to 125 mg/dl).

• Individuals with Hemoglobin (Hb%) (more than equal to 10 g/dl).

• Individuals with BP (blood pressure) (less than equal to 140/100 mm Hg)

• Individuals with normal haematology as assessed by CBC (complete blood counts)

• Individuals with TSH levels in between 0.4 mIU/L to 5.0 mIU/L

• Individuals with SGOT and SGPT within 2 X the Upper normal limit (ULN) and serum

• Individuals with creatinine within 1.5 X ULN

• Rome-IV diagnostic criteria: Individuals with more than 25% of bowel movements with Bristol stool types 1, 2 or 6,7 and have had recurrent abdominal pain, on average, at least 1 day/week in the last 3 months. And the pain is associated with two or more of the following criteria:

‣ Related to defecation

⁃ Associated with a change in frequency of stool

⁃ Associated with a change in form or appearance of stool as

⁃ assessed by Bristol stool types 1,2, 6 or 7.

⁃ Individuals meeting the above criteria for the last 3 months with

⁃ symptom onset at least 6 months before diagnosis

• Individuals with Abdominal pain severity (more than equal to 6 on a 11-point scale) at screening and during placebo run-in period.

• Individuals with IBS-SSS of at least 175 points at screening.

• Individuals who are mentally stable as assessed by Perceived Stress Scale (PSS) less than equal to 26 (Low to Moderate stress).

• Individuals who understand the nature and purpose of the study including the potential risks and side effects.

• Individuals who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.

• Individuals who are capable of filling the app-based digital form/diary.

Locations
Other Locations
India
Shivam Hospital
RECRUITING
Dombivali
Gleneagles Global Hospitals
RECRUITING
Hyderabad
Jaipur National University Institute of Medical Sciences and Research Centre
RECRUITING
Jaipur
Aster Aadhar Hospital
RECRUITING
Kolhāpur
D Y Patil
RECRUITING
Navi Mumbai
Samvedna Hospital
RECRUITING
New Colony
Dr. Naresh Bansal's Gastro & Liver Clinic
RECRUITING
New Delhi
Dhanwantari Hospital
RECRUITING
Pune
Silver Birch
RECRUITING
Pune
Vishwaraj hospital
RECRUITING
Pune
D Y Patil Hospital, Medical college and research centre
RECRUITING
Thāne
Shri. B. M. PatilMedical College,Hospital andResearch Centre
RECRUITING
Vijayapura
Contact Information
Primary
Dr. Sanjay Vaze, MBBS
sanjay.v@vediclifesciences.com
+918655670964
Backup
Asha More, BAMS
asha.m@vediclifesciences.com
Time Frame
Start Date: 2025-03-27
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 402
Treatments
Active_comparator: MIX 1
Humiome® Post LB postbiotic 300 mg , Human Milk Oligosaccharides 2'-O-fucosyllactose 300 mg 1 capsule per day orally
Active_comparator: MIX 2
Humiome® Post LB postbiotic 100 mg Human Milk Oligosaccharides 2'-O-fucosyllactose 500 mg 1 capsule per day orally
Placebo_comparator: Placebo
Microcrystalline 1 capsule per day orally
Related Therapeutic Areas
Sponsors
Leads: DSM Nutritional Products, Inc.

This content was sourced from clinicaltrials.gov