Clinical trial NCT06687720: A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the Management of Irritable Bowel Syndrome With Protein Digestion.
Official title: A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Management of Irritable Bowel Syndrome: A Randomized, Open Label, Placebo-Arm, Comparative, Interventional, Proof-of-Science Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Meteoric Biopharmaceuticals Pvt. Ltd.
First posted: 2024-11-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: change in Albumin/Globulin ratio
timeFrame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
measure: change in total serum protein
timeFrame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
measure: change in prealbumin levels
timeFrame: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
measure: Change in the lifestyle using the Scoring and Gradation
timeFrame: Day 01 (before administration) for baseline, and post-dose on Day 30.
measure: Scoring and Gradation of symptoms of irritable bowel syndrome
timeFrame: Day 01 (before administration) for baseline, and post-dose on Day 30.
Secondary outcomes:
measure: Performance of safety laboratory tests including Complete Blood Count (CBC)
timeFrame: on Day 30
measure: Performance of safety laboratory tests including Biochemical tests
timeFrame: on Day 30
measure: Performance of safety laboratory tests including Urinalysis
timeFrame: on Day 30
measure: Assessment of the effectiveness of the test treatment in terms of change in CRP levels
timeFrame: on Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
measure: Assessment of the effectiveness of the test treatment in terms of change in IL-6 levels
timeFrame: On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).
Other outcomes:
Locations:
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: