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

Not Applicable

• Conditions: Health Condition 1: E638- Other specified nutritional deficiencies

• Registration Number: CTRI/2024/07/070846
• Lead Sponsor: MicrobioTx Health Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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:

? Improvement with defecation

? Onset associated with a change in frequency of stool

? 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.

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified