CTRI

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CTRI Number

CTRI/2024/07/070846 [Registered on: 18/07/2024] Trial Registered Prospectively

Last Modified On:

01/10/2024

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Effectiveness of gut health profile using blood test for patients with Irritable Bowel Syndrome or Depression

Scientific Title of Study

Identify microbial and metabolic biomarkers for building gut profile of a.) Depression and b.) Irritable Bowel Syndrome

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Palok Aich
Designation	Director
Affiliation	MicrobioTx Health Private Limited
Address	363, 8th Main, 3rd Block, Koramangala, Bangalore Bangalore KARNATAKA 560034 India
Phone	09019343030
Fax
Email	hello@microbiotx.com

Details of Contact Person
Scientific Query

Name	Dr Palok Aich
Designation	Director
Affiliation	MicrobioTx Health Private Limited
Address	363, 8th Main, 3rd Block, Koramangala, Bangalore KARNATAKA 560034 India
Phone	09019343030
Fax
Email	hello@microbiotx.com

Details of Contact Person
Public Query

Name	Dr Palok Aich
Designation	Director
Affiliation	MicrobioTx Health Private Limited
Address	363, 8th Main, 3rd Block, Koramangala, Bangalore KARNATAKA 560034 India
Phone	09019343030
Fax
Email	hello@microbiotx.com

Source of Monetary or Material Support

Infrastructure and clinical support provided by Maulana Azad Medical College to conduct clinical trial

Internal funds and Karnataka government award money

Primary Sponsor

Name	MicrobioTx Health Private Limited
Address	363, 8th Main, 3rd Block, Koramangala, Bangalore, 560034
Type of Sponsor	Other [Startup]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ujjawal Sonika	Maulana Azad Medical College	Room No 209, 2nd floor academic block, G B Pant hospital NewÂ Delhi-110002 New Delhi DELHI	9718599252 usonika@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Maulana Azad Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E638\|\|Other specified nutritional deficiencies,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	59.00 Year(s)
Gender	Both
Details	For depression subgroup - Patients with mild-moderate-severe depression, as defined by ICD-11, classified on the basis of self-reported responses to The International Depression Questionnaire (IDQ) 3) For IBS subgroup - Patients with IBS as per Rome III diagnostic criteria. Rome III criteria for diagnosis of IBS is mentioned as below - A patient might have IBS if they recurrent abdominal pain or discomfort for at least three days a month for the last three months, associated with two or more of the following criteria: â— Improvement with defecation â— Onset associated with a change in frequency of stool â— Onset associated with a change in form or appearance of stool Symptom onset greater than 6 months prior to the diagnosis, with the above criteria fulfilled for the past 3 months. Discomfort means an uncomfortable sensation not described as pain. 4) Patients who have normal general health and normal findings on clinical history, physical examination, blood count, no other abnormal clinical or ultrasonographic findings will be included in this study.

ExclusionCriteria

Details

1. Any active illness, psychological and/or pathological condition or chronic
disease that would interfere with study participation in the opinion of the
Investigator.
2. Participants with a history of alcohol consumption exceeding 20 grams
per day (both male and female)
3. Participants taking immunosuppressants, tamoxifen, amiodarone and/or
perhexiline;
4. Participants who have taken antibiotics in the last 3 months
5. Type 2 diabetes mellitus on insulin, or other glucose lowering therapy (eg
GLP-1 agonists, SGLT2- inhibitors and DPP4 inhibitors)
6. Those who are on drugs, which are likely to induce insulin sensitization
such as estrogens, amiodarone, methotrexate, tamoxifen, pioglitazones
and metformin.
7. Concurrent gastrointestinal diagnosis with symptoms that could mimic
IBS
8. Pregnant and lactating females
9. Contraindications including bulimia nervosa, substance abuse, change in
dose/regime or introduction of vitamin E, C or high dose vitamin D, fish oil or probiotics.
10. Subjects who have undergone previous abdominal surgery except
appendectomy, caesarean section, tubal ligation, laparoscopic
cholecystectomy, hysterectomy or abdominal wall hernia repair

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Sensitivity: Sensitivity is defined as (the number of microbes called within normal range by both the standard of care and MicrobioTx)/(number of microbes called within normal range by the standard of care) and Specificity: Specificity is defined as (number of microbes called deficient by both the standard of care and by MicrobioTx)/(number of microbes called deficient by standard of care)	The single time point at which the data will be analysed will be 26 weeks from the start of the study.

Secondary Outcome

Outcome	TimePoints
Design probiotic formulation to improve gut health in NAFLD patients	The single time point at which the data will be analysed will be 1 year from the start of the study.

Target Sample Size

Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

29/07/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Disorders of Anxiety and Depression, as well Gastro-Intestinal disorders are two highly prevalent diseases with high burden on the healthcare system. Depression may overtake heart failure as the most prevalent disease in the world by 2030.

These diseases have two things in common - absence of a diagnostic marker, and the presence of gut microbial dysbiosis. Both these diseases are classified based on self-reported or clinically observable symptoms alone. Imbalances of the gut microbiota are also well documented. The human gut has the second-highest concentration of neurons after the brain, and several studies have shown that the gutâ€“brain axis influences the development of anxiety and depression. The importance of gut microbiota dysbiosis in IBS is highlighted by the fact that triggers for IBS such as infections, poor sleep, antibiotic use, diet, and stress can affect intestinal microbiota composition.

The major theme of the current proposal is to develop high-throughput, sensitive, and rapid metabolomic (MS/MS), and metagenomic (fecal microbiome) methodologies to correlate metabolite (from serum) and microbial (from fecal samples) markers in human patients for the above diseases.