A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the Management of Irritable Bowel Syndrome With Protein Digestion.

NCT06687720 | Not Yet Recruiting

• 1 other identifier: NB240026-MB
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (5)

• change in Albumin/Globulin ratio

  Evaluate the effect of the test treatment in terms of change in Albumin/Globulin ratio

  Baseline before and 6-8 hours post-dose on Day 01 and Day 30

• change in total serum protein

  Evaluate the effect of the test treatment in terms of change in total serum protein

  Baseline before and 6-8 hours post-dose on Day 01 and Day 30

• change in prealbumin levels

  Evaluate the effect of the test treatment in terms of change in prealbumin levels.

  Baseline before and 6-8 hours post-dose on Day 01 and Day 30

• Change in the lifestyle using the Scoring and Gradation

  Assessment of the effectiveness of the test treatment in terms of change in the lifestyle using the Scoring and Gradation. Severely disturbed lifestyle- 76%-100% Marked disturbed lifestyle-51%-75% Moderately disturbed lifestyle -25%-50% Mild disturbed lifestyle\<25

  Day 01 (before administration) for baseline, and post-dose on Day 30.

• Scoring and Gradation of symptoms of irritable bowel syndrome

  Evaluate of the effect of test treatment using Scoring and Gradation of symptoms of irritable bowel syndrome. Complete remission-76%-100% Marked improvement-51%-75% Mild improvement-25%-50% Unchanged\<25%

  Day 01 (before administration) for baseline, and post-dose on Day 30.

Secondary Outcomes (5)

• Performance of safety laboratory tests including Complete Blood Count (CBC)

  on Day 30

• Performance of safety laboratory tests including Biochemical tests

  on Day 30

• Performance of safety laboratory tests including Urinalysis

  on Day 30

• Assessment of the effectiveness of the test treatment in terms of change in CRP levels

  on Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).

• Assessment of the effectiveness of the test treatment in terms of change in IL-6 levels

  On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).

Study Arms (2)

MetBroma

EXPERIMENTAL

Active Ingredients: Bromelain Mode of Usage: Take one slow-release capsule twice a day, after meal with water Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day

Other: MetBroma

Placebo

PLACEBO COMPARATOR

Mode of Usage: Take one slow-release capsule twice a day, after meal with water Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day

Other: MetBroma

Interventions

MetBroma OTHER

Mode of Usage: Take one slow-release capsule twice a day, after meal Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day

MetBroma; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is an adult male or female aged between 18 to 60 years old.
• Clinically diagnosed with irritable bowel syndrome (IBS) based on Rome IV criteria: Abdominal pain at least 4 days per month - over at least 2 months - associated with one or more of the following:
• i. Related to defecation ii. A change in frequency of stool iii. A change in form (appearance) of stool iv. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
• The subject is having refrigerator at their home for storage of test treatment.
• The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
• The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
• The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
• If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
• i. Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
• ii. Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.

You may not qualify if:

• The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
• The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
• The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and probiotics or prebiotics supplements within the last 4 weeks.
• The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
• The subject has a history of alcohol abuse.
• The subject is either pregnant, lactating, or plans on conceiving during the course of the study.
• The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.
• The subject has other significant gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, celiac disease).
• The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.
• The subject has abnormal baseline Haemoglobin (Hb), Complete Blood Count (CBC), Urine Routine/Microscopy (R/M), or Stool Routine/Microscopy (R/M) results that suggest a different pathology than irritable bowel syndrome.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Meteoric Biopharmaceuticals Pvt. Ltd.: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013236; maheshvari@novobliss.in

Sheetal J Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 14, 2024
• Study Start: November 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share