What is the effect of increasing dietary resistant starch on gut health and immunity in HIV-positive adults in India and is a feeding trial feasible?

Not Applicable

• Conditions: HIV; Gastrointestinal dysbiosis; Gastrointestinal symptoms; Gut pathology syndrome; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Infection - Acquired immune deficiency syndrome (AIDS / HIV); Inflammatory and Immune System - Other inflammatory or immune system disorders; Public Health - Other public health

• Registration Number: ACTRN12619000739112
• Lead Sponsor: Flinders University of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-17
• Study Completion: 2020-09-02
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1.) HIV-positive adults aged 18 years or over on Anti Retroviral Therapy (ART); 2.) CD4+ T cell count more than 200 cells/mm3; 3.) No antibiotic usage within last 6 weeks.

Exclusion Criteria

1.) Co-morbidities affecting the gastrointestinal tract such as Crohn’s Disease, Ulcerative Colitis. 2.) Current participation in other interventional studies; 3.) Pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pH of stool samples, Supernatant pH will be measured using a pH meter (Mettler-Toledo Ltd.) on a scale of 1-14.[Days 0, 15, 28, 43, 56, 71, 84, 99 and 112 where 'day 0' indicates the day preceding the first day (day 1) of phase 1 of the crossover study. On day 1, commencement of the first randomly-assigned feeding intervention will begin ('study intervention' or 'control intervention').]