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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)

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ClinicalTrials.gov Identifier: NCT04015986
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Background (brief):

  1. Burden: A total of 52 million children under 5 are suffering from acute malnutrition globally, of whom 33 million suffer from moderate acute malnutrition (MAM). In Bangladesh, around 2 million children suffer from MAM. In absolute numbers, according to Bangladesh Demographic Health Survey 2014, 26%, 25% and 17% of children aged less than two years are stunted, underweight and wasted respectively.1
  2. Knowledge gap: We have already demonstrated that children with acute malnutrition have immature gut microbiota that is partially corrected with treatment. Children with MAM have an increased risk of mortality, infections and impaired physical and cognitive development compared to well-nourished children. Although the global caseload of MAM is much greater than that of SAM, the condition has not received the same level of attention or priority. Through our previous and ongoing research we now know about the members of the gut microbiota that can promote growth in children and also about certain food ingredients that promote the proliferation of such beneficial microbiota. However, this knowledge needs to be applied on a large scale community-based clinical trial.
  3. Relevance: The rationale for this study is to assess whether long-term administration of complementary food made of locally available food ingredients that can stimulate the proliferation of growth promoting gut microbiota (MDCF-2), as identified in our Pre-POC trial, is able to produce predictable changes in the microbiota of Bangladeshi children with Post-SAM MAM as well as in their nutritional status. We would now like to do a community-based clinical trial of this potential MDCF-2 in the management of children with Post-SAM MAM.

Hypothesis (if any): Complementary foods made of locally available food ingredients that stimulate the proliferation of growth promoting gut microbiota (MDCF-2) will improve clinical outcomes.

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

Methods: We will conduct a proof of concept (POC) clinical trial in 12-18 months old children with post-SAM MAM (Weight-for-Length Z-score, WLZ <-2 to -3) over the course of approximately two years. This study will be undertaken at Mirpur area of Dhaka city and in Kurigram. We will produce MDCF-2 at the icddr,b Food Processing Laboratory in sufficient quantities for the trial. This formulation is matched for energy density and micronutrient content of ready to use supplementary food (RUSF) used for MAM. It itself is not a ready-to-use food but is rather a cooked food made of locally available food ingredients (chickpea, green banana, peanut, soybean flour) which have been found to enhance growth promoting members of the gut microbiota in children. We will test MDCF-2 and the current RUSF standard of care for Post SAM MAM to see the effect on growth, proteomics and metabolomics of an intervention for 12 weeks, with a 4-week post-intervention phase.

Outcome measures/variables:

  • 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


Condition or disease Intervention/treatment Phase
Microbiota Complementary Food Nutrition Dietary Supplement: Microbiota Directed Complementary Food-2 Dietary Supplement: Ready to Use Supplementary Food Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Microbiota Directed Complementary Food (MDCF) Post-SAM MAM Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Intervention arm
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
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
Other Name: MDCF-2

Active Comparator: Control arm
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
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)
Other Name: RUSF




Primary Outcome Measures :
  1. Change in Ponderal growth [ Time Frame: 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 ]
    Rate of weight gain of the enrolled participants

  2. Change in Liner growth (LAZ) [ Time Frame: 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 ]
    Rate of skeletal human growth

  3. Change in Proteomic profile [ Time Frame: 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. ]
    Information about all proteins that are made in blood, other body fluids, or tissues, at certain times.It will be assayed by Somalogic scan

  4. Change in Morbidity [ Time Frame: 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. ]
    Refers to having a disease or a symptom of disease. It will be assessed by taking morbidity data

  5. Change in Microbiota-for-Age Z (MAZ) score [ Time Frame: 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • Medical conditions: Children with tuberculosis (diagnosis based on WHO 2014 guidelines which have been incorporated in the national TB control guidelines of Bangladesh). The guidelines depend upon the following five diagnostic principles (three out of five should be positive): 1. Specific symptoms of TB, 2. Specific signs, 3. Chest X-ray, 4. Mantoux test, and 5. History of contact,[9] or any congenital/acquired disorder affecting growth i.e. known case of trisomy-21 or cerebral palsy; children on an exclusion diet for the treatment of persistent diarrhea; having known history of soy, peanut or milk protein allergy- Severe anemia (<8mg/dl), will be assessed by Hemocue (Model no. Hemocue Hb 301)
  • Failure to obtain informed written consent from parents or caretakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015986


Contacts
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Contact: Tahmeed Ahmed, PhD, MBBS 01713044799 ext 2300 tahmeed@icddrb.org
Contact: Mustafa Mahfuz, MPH, MBBS 01712214205 ext 2304 mustafa.mahfuz@icddrb.org

Locations
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Bangladesh
Icddr,B Recruiting
Dhaka, Bangladesh, 1212
Contact: Tahmeed Ahmed, PhD, MBBS    01713044799 ext 2300    tahmeed@icddrb.org   
Contact: Mustafa Mahfuz, MPH, MBBS    01712214205 ext 2304    mustafa.mahfuz@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Washington University School of Medicine
Investigators
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Principal Investigator: Tahmeed Ahmed, PhD, MBBS Senior Director, Nutrition & Clinical Services Division, icddr,b
Study Chair: 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

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT04015986     History of Changes
Other Study ID Numbers: PR-18079
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Severe Acute Malnutrition
Malnutrition
Nutrition Disorders