A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects Having Symptoms of Gut Dysbiosis (Heart Burn, Bloating, Constipation and Gut Immunity).

NCT06572358 | Completed

• 1 other identifier: NB240019-MB
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation).

Conditions

Gut Dysbiosis

Outcome Measures

Primary Outcomes (18)

• Changes in stool consistency based on the Bristol Stool Criteria

  To evaluate the effectiveness of the test product in terms of change in stool based on the Bristol Stool Criteria categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhoea).

  Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90

• Change in faecal microbiota using 16s Metagenome sequencing

  To evaluate the effectiveness of test product in terms of change in faecal microbiota using 16s Metagenome sequencing

  Baseline at Day 1, and on Day 90.

• Abbreviated physical examinations in terms of frequency of sensation of defecation

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of frequency of sensation of defecation according to a 5-point Likert scale, with a score ranging from 0 (no symptoms) to 20 (very severe symptoms

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of bloating

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of bloating in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of nausea

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of nausea where scoring determined no nausea=0, mild nausea=1-2, moderate nausea 3-6, and severe nausea7-9

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of altered bowel habit.

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of altered bowel habit in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of digestion issues

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of digestion issues in which scoring done on yes or no

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of aching joints

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of aching joints in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of chronic fatigue

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of chronic fatigue in which scoring done as less than 1 week=1, less than1 month=2, less than 6 months=3 and more than 6 months=4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of constipation for Frequency of bowel movements

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Frequency of bowel movements in which scoring done 1-2 times per 1-2 days=1 and less than once per month=4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation in which scoring done never=0 and always=4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt in which scoring done Less than 5=0 and More than 30=4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours in which scoring done never=0 and More than 9 =4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort in which scoring done never=0 and always =4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of constipation for Pain: abdominal pain

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Pain: abdominal pain in which scoring done never=0 and always =4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of constipation for Assistance: type of assistance

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Assistance: type of assistance in which scoring done without assistance=0 and Digital assistance or enema =2

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of constipation for History: duration of constipation (years)

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for History: duration of constipation (years) in which scoring done 0=0 and more than 20 =4

  Baseline Day 1, Day 45 and on Day 90

• Abbreviated physical examinations in terms of diarrhoea

  To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of diarrhoeawhere score, severe diarrhea - having more than 10 loose, watery stools in a single day (24 hours). Moderate diarrhea -having more than a few but not more than 10 diarrhea stools in a day and Mild

  Baseline Day 1, Day 45 and on Day 90

Secondary Outcomes (43)

• Effectiveness by biomarkers like CRP (C reactive protein).

  baseline Day 01 and after usage of the test product on Day 90.

• Effectiveness by biomarkers like IL-6 (Interleukin-6).

  baseline Day 01 and after usage of the test product on Day 90.

• Effectiveness of the test product in terms of subject perception questionnaire where scoring by licert scale where 1 = not at all and 5=Extremely

  Baseline before usage of the test product on Day 01 and after usage of the test product, on Day 45 and on Day 90

• change in lab parameters-Hemoglobin

  Baseline on Day -01 and after usage of the test product on Day 90.

• change in lab parameters-Hematocrit

  Baseline on Day -01 and after usage of the test product on Day 90.

Study Arms (1)

MetProUltima

EXPERIMENTAL

Test product Name: MetProUltima Marketed By\| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral

Other: MetProUltima

Interventions

MetProUltima OTHER

Test product Name: MetProUltima Marketed By\| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral

MetProUltima

Eligibility Criteria

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

You may qualify if:

• Age: 18 to 65 years (both inclusive) at the time of consent.
• Sex: Healthy males and healthy non-pregnant/non-lactating females.
• Females of childbearing potential must have a self-reported negative pregnancy test.
• Subject should have refrigerator at their home for storage of test product.
• Subjects having history of falling sick frequently in two months.
• Subjects having gut dysbiosis with either of these three symptoms which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
• If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
• Subjects are willing to give written informed consent and are willing to come for regular follow-up.
• Subjects who commit not to use other probiotics, symbiotic, prebiotics, medicated treatments or food having high probiotics other than the test product for the entire duration of the study.
• Subject who has not participated in a similar investigation in the past three months.
• Willing to use test product throughout the study period.

You may not qualify if:

• Subject with suspected or proved organic causes of constipation, such as Hirschsprung's disease, hypothyroidism, or structural anomalies of the anal canal.
• Subject with present condition of allergic response to any probiotic product.
• Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
• Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
• History of alcohol or drug addiction.
• Subjects with a history of major gastrointestinal complications (i.e. Crohn's disease, ulcer, cancer, ulcerative colitis).
• Subjects who have self-reported immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis).
• Pregnant or breastfeeding or planning to become pregnant during the study period.
• Subjects participating in other similar product or therapeutic trials within the last four weeks.

Sponsors & Collaborators

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

Study Sites (1)

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382481, India

Location

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Open-label, Single-arm, Proof of science

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 27, 2024
• Study Start: October 22, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)