Community-based Clinical Trial With Microbiota Directed Complementary Foods (MDCFs) Made of Locally Available Food Ingredients for the Management of Children With Post-severe Acute Malnutrition Moderate Acute Malnutrition (Post-SAM MAM)

NCT04015986 | Unknown Phase 2 DMC

• 1 other identifier: PR-18079
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Background (brief):

• Ponderal growth (rate of weight gain as the primary outcome variable), measured at different time points by anthropometry
• Linear growth, measured at different time points by anthropometry
• Proteomic profile, assayed by DNA aptamer based SOMAlogic scan
• Morbidity, assessed by daily records
• Change in microbiota-for-age Z score Hypothesis to be tested: Complementary food made of locally available food ingredients that can stimulate the proliferation of growth promoting gut microbiota (MDCF-2) will improve nutritional outcomes. Specific Objectives To investigate the efficacy of complementary food made of locally available food ingredients that can stimulate the proliferation of growth promoting gut microbiota (Microbiota Directed Complementary Food: MDCF-2) in (i) promoting repair of microbiota immaturity (ii) promoting proliferation of beneficial bacteria (iii) improving both linear and ponderal growth in children with Post-SAM MAM (iv) improving the metabolomic profile of children with Post-SAM MAM

Conditions

Microbiota; Complementary Food; Nutrition

Outcome Measures

Primary Outcomes (5)

• Change in Ponderal growth

  Rate of weight gain of the enrolled participants

  At the enrollment (day1), every day during acute phase and nutritional rehabilitation phase, every 15 days during the 3 months of intervention phase and at the end of 1 month of follow up phase by anthropometry

• Change in Liner growth (LAZ)

  Rate of skeletal human growth

  At the enrollment (day1), every week during the acute phase and nutritional rehabilitation phase, every 15 days during the 3 months of intervention phase and at the end of 1 month of follow up phase by anthropometry

• Change in Proteomic profile

  Information about all proteins that are made in blood, other body fluids, or tissues, at certain times.It will be assayed by Somalogic scan

  A total of 4 plasma samples will be collected, at enrollment, prior to 3 months of intervention, end of first month of intervention and just after the completion of intervention.

• Change in Morbidity

  Refers to having a disease or a symptom of disease. It will be assessed by taking morbidity data

  Data will be collected every day from enrollment, during the acute and rehabilitation phase, 3 months of intervention phase and once at the end of 1 month of follow up phase.

• Change in Microbiota-for-Age Z (MAZ) score

  bacterial species whose proportional representation define a healthy gut microbiota as it assembles during the first two postnatal years of life. 'microbiota-for-age Z-score' compares development of a child's fecal microbiota relative to healthy children of similar chronologic age.

  At enrollment, every alternative day during the stabilization phase, once during the nutritional rehabilitation phase, weekly during the first month of intervention, at the end of 2nd and 3rd months of intervention & at the end of 1 month of follow up.

Study Arms (2)

Intervention arm

EXPERIMENTAL

MDCF-2 prototype with four complimentary food ingredients without powdered milk (rationale: lead with evidence from the recently completed pre-POC clinical trial of promoting growth promoting microbiota and positive effects on growth).

Dietary Supplement: Microbiota Directed Complementary Food-2

Control arm

ACTIVE COMPARATOR

Rice-lentil based RUSF (rationale: reference standard of care for post-SAM, MAM; based on knowledge of its effects on child growth and the gut microbiota)

Dietary Supplement: Ready to Use Supplementary Food

Interventions

Microbiota Directed Complementary Food-2 DIETARY_SUPPLEMENT

MDCF prototype with four complimentary food ingredients without powdered milk (rationale: lead with evidence from the recently completed pre-POC clinical trial of promoting growth promoting microbiota and positive effects on growth

Also known as: MDCF-2

Intervention arm

Ready to Use Supplementary Food DIETARY_SUPPLEMENT

Rice-lentil based RUSF (rationale: reference standard of care for post-SAM, MAM; based on knowledge of its effects on child growth and the gut microbiota)

Also known as: RUSF

Control arm

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent(s) willing to sign consent form; the informed consent document will explicitly request permission to use the collected fecal samples for future studies, including but not limited to culturing component bacterial strains
• Child age 12-18 months
• WLZ between \<-2 and -3 without bilateral pedal edema at the time of randomization
• Parent(s) willing to bring the child to the feeding centre twice daily for 4 weeks for nutritional therapy, once daily for next 4 weeks and administer the feeds provided by study staff once daily at home for 4 weeks and twice daily for next 4 weeks.

You may not qualify if:

• Failure to obtain informed written consent from parents or caretakers

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Icddr,B

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (1)

• Mostafa I, Nahar NN, Islam MM, Huq S, Mustafa M, Barratt M, Gordon JI, Ahmed T. Proof-of-concept study of the efficacy of a microbiota-directed complementary food formulation (MDCF) for treating moderate acute malnutrition. BMC Public Health. 2020 Feb 17;20(1):242. doi: 10.1186/s12889-020-8330-8.

  PMID: 32066412 DERIVED

Study Officials

• Tahmeed Ahmed, PhD, MBBS

  Senior Director, Nutrition & Clinical Services Division, icddr,b

  PRINCIPAL INVESTIGATOR

• Munirul Islam, PhD, MBBS

  Senior Scientist, Nutrition and Clinical Services Division, icddr,b

  STUDY CHAIR

• Sayeeda Haque, MPH, MBBS

  Associate scientist, Nutrition and Clinical Services Division, icddr,b

  STUDY CHAIR

• Ishita Mostafa, MPH, MBBS

  Research Investigator, Nutrition and Clinical Services Division, icddr,b

  STUDY CHAIR

• Imteaz Mahmud, MBBS

  Research Fellow, Nutrition and Clinical Services Division, icddr,b

  STUDY CHAIR

• Nurun Nahar Naila, MPH, MBBS

  Assistant Scientist, Nutrition and Clinical Services Division, icddr,b

  STUDY CHAIR

• Mustafa Mahfuz, MPH, MBBS

  Associate scientist, Nutrition & Clinical Services Division, icddr,b

  STUDY CHAIR

Central Study Contacts

Tahmeed Ahmed, PhD, MBBS

CONTACT

01713044799; tahmeed@icddrb.org

Mustafa Mahfuz, MPH, MBBS

CONTACT

01712214205; mustafa.mahfuz@icddrb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: July 11, 2019
• Study Start: November 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-01

Locations

BA (1)