Clinical trial NCT06572358: 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).
Official title: A 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, and Gut Immunity).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Dysbiosis
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Meteoric Biopharmaceuticals Pvt. Ltd.
First posted: 2024-08-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Open-label, Single-arm, Proof of science
Primary purpose: OTHER

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).

Detailed description: A total of up to 14 subjects will be enrolled to get 12 evaluable subjects complete the study.

The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects having symptoms of gut dysbiosis like burning sensation, bloating nausea and altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea will be enrolled in the study. The subjects will be instructed to visit the facility as per the below visits.

Visit 01 (Day -01): Screening, Blood Sample Collection Visit 02 (Day 01): Enrolment, Faecal Sample Collection, Test Product Dispensing Visit 03 (Day 45 ±2 Days): Treatment usage period, Evaluations Visit 04 (Day 90 ±2 Days): Treatment usage period, Evaluations and End of study.

Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 65 years (both inclusive) at the time of consent.
2. Sex: Healthy males and healthy non-pregnant/non-lactating females.
3. Females of childbearing potential must have a self-reported negative pregnancy test.
4. Subject should have refrigerator at their home for storage of test product.
5. Subjects having history of falling sick frequently in two months.
6. 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.
7. 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).
8. Subjects are willing to give written informed consent and are willing to come for regular follow-up.
9. 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.
10. Subject who has not participated in a similar investigation in the past three months.
11. Willing to use test product throughout the study period.

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in stool consistency based on the Bristol Stool Criteria
timeFrame: Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90
measure: Change in faecal microbiota using 16s Metagenome sequencing
timeFrame: Baseline at Day 1, and on Day 90.
measure: Abbreviated physical examinations in terms of frequency of sensation of defecation
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of bloating
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of nausea
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of altered bowel habit.
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of digestion issues
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of aching joints
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of chronic fatigue
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of constipation for Frequency of bowel movements
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of constipation for Pain: abdominal pain
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of constipation for Assistance: type of assistance
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of constipation for History: duration of constipation (years)
timeFrame: Baseline Day 1, Day 45 and on Day 90
measure: Abbreviated physical examinations in terms of diarrhoea
timeFrame: Baseline Day 1, Day 45 and on Day 90
Secondary outcomes:
measure: Effectiveness by biomarkers like CRP (C reactive protein).
timeFrame: baseline Day 01 and after usage of the test product on Day 90.
measure: Effectiveness by biomarkers like IL-6 (Interleukin-6).
timeFrame: baseline Day 01 and after usage of the test product on Day 90.
measure: Effectiveness of the test product in terms of subject perception questionnaire where scoring by licert scale where 1 = not at all and 5=Extremely
timeFrame: Baseline before usage of the test product on Day 01 and after usage of the test product, on Day 45 and on Day 90
measure: change in lab parameters-Hemoglobin
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Hematocrit
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-RBC Counts (Red Blood Corpuscle)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-MCV (Mean corpuscular volume)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-MCH (mean corpuscular hemoglobin)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-MCHC (Mean corpuscular hemoglobin concentration)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-RDW (Red cell distribution width)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-WBC Counts (White blood cells)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Neutrophils
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Lymphocytes
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Eosinophils
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Monocytes
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Basophils
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-RBC morphology
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Platelet Count
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Random Blood Sugar
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Total Serum Cholesterol
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Triglyceride
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-HDL (High-density lipoprotein cholesterol)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-LDL (Low-density lipoprotein)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in lab parameters-Serum Creatinine
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Color
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Transparency
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Specific Gravity
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -pH
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Albumin
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Glucose
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Bile Salts
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Bile Pigments
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Bilirubin
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Urobilinogen
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Ketone
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Nitrite
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Leucocyte
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -WBC (White blood cell)
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Epithelial Cell
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Casts
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: change in Urine Routine and Microscopy -Crystals
timeFrame: Baseline on Day -01 and after usage of the test product on Day 90.
measure: Adverse events
timeFrame: Baseline Day 1, Day 45 and on Day 90
Other outcomes:
Locations:
city: Ahmadabad
country: India
facility: NovoBliss Research Pvt.Ltd
state: Gujarat
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: