| CTRI Number |
CTRI/2023/01/048716 [Registered on: 03/01/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional Supplements Trial ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Elimination of malnutrition using Microbiota-directed complementary foods in children with moderate malnutrition |
|
Scientific Title of Study
|
Microbiota-directed complementary foods to treat children with moderate acute malnutrition in the first two years of life – Open label Randomized controlled Pre-proof of Concept (MDCF prePOC) study |
| Trial Acronym |
MDCF prePOC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MDCF prePOC version 1.1 dated 24 Nov 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gagandeep Kang |
| Designation |
Overall Principal Investigator |
| Affiliation |
Christian Medical College (CMC), Vellore |
| Address |
The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College (CMC), Vellore, Tamil Nadu, India
Vellore
TAMIL NADU
632002
India |
| Phone |
9894070266 |
| Fax |
|
| Email |
gkang@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Apte |
| Designation |
Principle Investigator |
| Affiliation |
KEM Hospital Research center, Pune |
| Address |
KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, Pune – 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9975950227 |
| Fax |
|
| Email |
aditi.apte@kemhrcvadu.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gagandeep Kang |
| Designation |
Overall Principal Investigator |
| Affiliation |
Christian Medical College (CMC), Vellore |
| Address |
The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College (CMC), Vellore, Tamil Nadu, India
Vellore
TAMIL NADU
632002
India |
| Phone |
9894070266 |
| Fax |
|
| Email |
gkang@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| FUNDER: Sun Pharma Advanced Research Company, Mumbai.
|
|
|
Primary Sponsor
|
| Name |
Christian Medical College (CMC), Vellore |
| Address |
The Wellcome Trust Research Laboratory,
Division of Gastrointestinal Sciences, Christian Medical College (CMC), Vellore, Tamil Nadu, India
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bireshwar Sinha |
Centre for Health Research and Development Society for Applied Studies (CHRD SAS) |
45, Kalu Sarai, New Delhi-110016
New Delhi
DELHI |
7838019667
bireshwar.sinha@sas.org.in |
| Dr Sam Marconi D |
Christian Medical College (CMC) |
The Wellcome Trust Research Laboratory,
Division of Gastrointestinal Sciences, Vellore, Tamil Nadu, India
Vellore
TAMIL NADU |
9841582702
sammarconi@cmcvellore.ac.in |
| Dr Aditi Apte |
KEM Hospital Research Centre |
Community Health Research unit
4th floor, Prajakta Hospital, Mulewadi Road, P.O Manchar, Taluka Ambegaon
District- Pune. 410503, Maharashtra, India
Pune
MAHARASHTRA |
9975950227
aditi.apte@kemhrcvadu.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Review Committee Centre for Health Research and Development Society for Applied Studies |
Approved |
| INSTITUTIONAL REVIEW BOARD CHRISTIAN MEDICAL COLLEGE |
Approved |
| KEM Hospital Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To treat children with moderate acute malnutrition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
(MDCF)Microbiota-directed complementary foods |
1) Components:
MDCF (g/100g)(
Bengal gram dal flour- 13g,
Peanut paste- 13g,
Soybean flour (brown)- 11g,
Green Banana powder- 15 g,
Sugar Crushed- 22g,
Soybean oil- 23g,
Micronutrient mix- 3 g).
2) How many nutrients per 100 grams:
(Protein- 10.4,
Fat- 31.3,
Carbohydrate- 44.9,
Fibre- 7.2,
Protein-energy ratio- 8.32,
Fat-energy ratio- 56.45,
Total calories (per 100g)- 499.3).
3) Food Dose: Children aged 6-12 months will be offered 18 gm of MDCF per meal (i.e., 36 gm supplement daily) and children aged 12-18 months will be offered 25 gm of MDCF per meal (i.e., 50 gm supplement daily).
4) Based on allocation the child will be fed with MDCF twice daily for 4 weeks.
|
| Comparator Agent |
(RUSF) Ready to use supplementary food |
1) RUSF (g/100g):
(Whole Wheat- 9 g,
Rice raw milled 9 g,
Jaggery- 22g,
Green gram dal 15 g,
Groundnut oil- 22 g,
Peanut paste 20 g,
Micronutrient mix - 3 g).
2) How many nutrients per 100 grams:
(Protein- 10.49,
Fat- 30.3,
Carbohydrate- 42.9,
Fibre- 4.7,
Protein-energy ratio- 8.47,
Fat-energy ratio- 55.69,
Total calories (per 100g)- 490.0).
3) Food Dose: Children aged 6-12 months will be offered 18 gm of RUSF per meal (i.e., 36 gm supplement daily) and children aged 12-18 months will be offered 25 gm of RUSF per meal (i.e., 50 gm supplement daily).
4) Based on allocation the child will be fed with RUSF twice daily for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
90.00 Day(s) |
| Age To |
18.00 Month(s) |
| Gender |
Both |
| Details |
INTERVENTIONAL COHORT:
1. Children aged 6-18 months of either gender and no longer exclusively breastfed
2. Weight to length Z (WLZ) score <−2 to -3 without bilateral pedal edema at the time of randomization (for MAM children)
3. Parent(s) willing for study participation and aid in following study procedures
4. Agree to remain in the study area for the study duration
HEALTHY COHORT:
1. Age between 90 days to 119 days (3 to < 4 months)
2. Anthropometric scores (WLZ above -1SD)
3. Willing to stay in the study area for 2 years
|
|
| ExclusionCriteria |
| Details |
INTERVENTIONAL COHORT:
1. Any ongoing fever or medical condition persisting for >last 14 days or requires hospitalization
2. Any congenital/acquired disorder affecting growth
3. History of soy, milk protein or peanut allergy
4. Severe pallor on examination
5. Antibiotic use (within last 15 days before the onset of intervention)
6. Ongoing maternal antibiotic usage for breastfeeding infants
7. Receiving concurrent treatment for another condition
8. Failure to obtain informed written consent from parents/guardians
9. Any other condition that in the opinion of the study investigator serves as an exclusion
Note: Criteria No 1, 4, 5,7 will be temporary exclusion criterion, children will be eligible for inclusion if they are not having any medical conditions, severe pallor, antibiotic use on any concurrent treatment for last 15 days from the day of enrolment.
HEALTHY COHORT:
1. No history of antibiotic consumption in the past 15 days (temporary exclusion)
2. History of any medical illness in the past 15 days (temporary exclusion)
3. Any medical condition persisting for >last 14 days prior to enrolment or requires hospitalization (temporary exclusion))
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Acceptability of the food supplements (MDCF and RUSF) amongst study participants and caregivers and compliance to the intervention.
2. Feasibility of collection, transport and storage of fecal samples |
1. At week 2 to Week 6 from enrollment
2. during overall study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Microbiota for age Z-score (MAZ). |
At week 0 to week 8 except week 7 for the interventional cohort and every month of healthy cohort |
| Enteropathogenic burden (estimated using PCR-based analysis of the fecal samples) |
end of study |
| Weight-for-length z-score (WLZ), weight-for-age z-score (WAZ), length-for-age z-score (LAZ) and mid-upper arm circumference (MUAC) at the end of the study. |
At week 8 from enrollment |
| Metabolic markers: Plasma proteomic profile (including mediators of bone growth and ossification, proteins associated with ponderal growth, and CNS development). |
At week 2 and week 6 from enrollment |
|
|
Target Sample Size
|
Total Sample Size="630"
Sample Size from India="630"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="630" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute malnutrition amongst under five children is a significant public health problem in India and leads to adverse consequences on survival, growth and development. Recently conducted studies have demonstrated impaired gut microbiota development in children with acute malnutrition during the first two years of life with lower microbiota for age Z-score (MAZ) compared to healthy infants. This microbiota immaturity may not be repaired by existing nutritional interventions. Microbiota directed food supplement (MDCF) is a specialised nutritional intervention developed through a series of research studies conducted in Bangladeshi children which has demonstrated potential for repairing the defect in the gut microbial community and is associated with improved growth and development in children aged 12-18 months. We plan to assess the acceptability, generalisability and efficacy of MDCF in Indian children with moderate acute malnutrition (MAM) aged 6-18 months in geographically different locations in India (Delhi, Pune and Vellore). The study will be conducted in 2 phases, i.e. the pre-proof of concept (prePOC) study and the proof of concept (POC) study. In the prePOC study, the primary purpose is to assess acceptability and feasibility of delivering the intervention. In the latter phase, we will evaluate generalisability and efficacy of the intervention. The present prePOC study is a multi-centric (3-site) study to establish the acceptability and feasibility of the intervention and to establish the systems for sample collection, storage and transport. Total 80 children with MAM (40 aged 6-<12 months, and 40 aged 12 -18 months) will be enrolled at each site. Each age strata will be randomised in 1:1 ratio to receive MDCF or ready-use supplementary food (RUSF) for a period of 4 weeks. MDCF will be freshly prepared daily in the study sites. The food supplements will be delivered under direct observation by health workers. The study participants will undergo fecal sample collection every week for assessment of the gut microbiome. Blood samples (2-3 ml) will be collected at baseline and at the end of the intervention to assess the plasma proteomic profile. The children will be followed up for 2 weeks after the end of the intervention to assess whether changes in the gut microbial community are sustained post-intervention. The primary outcome parameters will include acceptability and compliance to the intervention, feasibility of the intervention and biological specimen collections. Secondary outcomes are changes in microbiota for age Z scores (MAZ), enterobacterial burden, and change in the plasma proteomic profile. Additionally, a cohort of 130 healthy children aged 3-months at each site will be longitudinally followed up for 24 months and their fecal samples will be collected every month to establish a reference MAZ score in the population for comparing against children with MAM. |