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

NCT ID: NCT06687720

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2024-11-30

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.

Detailed Description

A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study.

Subjectsshall be instructed to visit the facility for the following scheduled visits:

• Visit 01 [Within 30 days]: Screening, Blood Parameter Assessment.
• Visit 02 [Day 01]: Enrolment, Evaluations, Treatment Dispensing.
• Visit 03 [Day 15 (±2 days)]: Telephonic follow-up.
• Visit 04 [Day 30 (±2 days)]: Treatment End, Final Evaluations.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MetBroma

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

Group Type: EXPERIMENTAL

MetBroma

Intervention Type: 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

Placebo

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

Group Type: PLACEBO_COMPARATOR

MetBroma

Intervention Type: 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

Interventions

MetBroma

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. The subject is an adult male or female aged between 18 to 60 years old.

2. 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

3. The subject is having refrigerator at their home for storage of test treatment.

4. The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.

5. The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.

6. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.

7. 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.

Exclusion Criteria

1. The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.

2. The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.

3. 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.

4. The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.

5. The subject has a history of alcohol abuse.

6. The subject is either pregnant, lactating, or plans on conceiving during the course of the study.

7. The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.

8. The subject has other significant gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, celiac disease).

9. The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.

10. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meteoric Biopharmaceuticals Pvt. Ltd.

INDUSTRY

Sponsor Role: collaborator

NovoBliss Research Pvt Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Nayan K Patel

Role: PRINCIPAL_INVESTIGATOR

NovoBliss Research Pvt Ltd

Central Contacts

Maheshvari N Patel

Role: CONTACT

maheshvari@novobliss.in

09909013236

Sheetal J Khandwala

Role: CONTACT

bd@novobliss.in

Other Identifiers

NB240026-MB

Identifier Type: -

Identifier Source: org_study_id