Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

Обзор

This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.

Вмешательства

• Пищевая добавка MDF
  MDF will be provided to children on a weekly basis for children with SAM and bi-weekly basis for children with MAM at the health center until programmatic recovery but not thereafter.
• Пищевая добавка RUTF
  RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter
• Пищевая добавка RUSF
  RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter

Первичные конечные точки

• Programmatic recovery by 12 weeks from admission [Срок оценки: 12 weeks]
• Sustained recovery at 24 weeks from admission [Срок оценки: 24 weeks]

Вторичные конечные точки (12)

• Default [Срок оценки: 12 weeks]
• Non-response [Срок оценки: 12 weeks]
• Time to recovery [Срок оценки: 12 weeks]
• For MAM children: Deterioration to SAM [Срок оценки: 24 weeks]
• Change in weight gain [Срок оценки: From enrollment to 4, 8 and 12 weeks]
• Change in weight-for-length Z (WLZ) [Срок оценки: From enrollment to 4, 8 and 12 weeks]
• Change in length-for-age Z (LAZ) [Срок оценки: From enrollment to 4, 8 and 12 weeks]
• Change in weight-for-age Z (WAZ) [Срок оценки: From enrollment to 4, 8 and 12 weeks]
• Change in MUAC [Срок оценки: From enrollment to 4, 8 and 12 weeks]
• Serious adverse events [Срок оценки: 24 weeks]
• Hospitalization [Срок оценки: 24 weeks]
• Death [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• for children with Severe Acute Malnutrition (SAM): MUAC < 115 mm and/or WLZ < -3 and/or mild (+) or moderate (++) edema
• for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC < 125 mm and/or -3 ≤ WHZ < -2
• Caregiver providing informed consent

Критерии исключения

• Medical complications requiring inpatient treatment, as identified by the national protocol
• Not eating/lack of appetite (as informed by appetite test and investigator judgement)
• Re-admission into the program within 2 months of previous default
• for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)
• for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)
• Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection
• Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)
• Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Niger · 1 центр

• Epicentre Niger — Maradi

Идентификаторы

NCT: NCT06382857 · 823779-MDF Niger

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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