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Modifying Intestinal integrity and MicroBiome in severe Malnutrition with LEgume-based feeds

Modifying Intestinal Integrity and MicroBiome in severe Malnutrition with LEgume-based feeds [MIMBLE Study]: A Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201805003381361
Enrollment
90
Registered
2018-05-12
Start date
2016-01-25
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine Paediatrics Malnutrition

Interventions

F75 and F100 Nutritional Milk feeds
B. Standard treatment WHO feeds (F75/F100) plus a non-digestible fermentable carbohydrate as inulin
Cereal-based recipe for WHO feeds (F75/F100) plus a non-digestible fermentable carbohydrate as cowpe

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Anthropometric features of severe acute malnutrition as per WHO Child Growth Standards (2006): 1. Marasmus: Mid-upper arm circumference (MUAC) <11.5cm or Weight-for-height Z-score (WHZ) < -3 2. Kwashiorkor: Symmetrical pitting oedema involving at least the feet irrespective of WHZ score or MUAC 3. Guardian or parent willing and able to provide consent

Exclusion criteria

Exclusion criteria: Children with severe acute malnutrition with a very high risk of early death will be excluded: ¿ Impaired consciousness: one of prostration (inability to sit unsupported or inability to breast feed if 3s, lower limb temperature gradient or weak radial pulse volume. ¿ Severe dehydration: Sunken eyes and reduced skin turgor in the presence of diarrhoea (3 or more episodes of profuse and watery stool) ¿ Respiratory distress: increased work of breathing and hypoxia (oxygen saturation < 90% in air) Additionally children who cannot complete accurate dietary recall will be excluded: ¿ Exclusively breast-fed infants

Design outcomes

Primary

MeasureTime frame
Co-primary outcome measures: 1.Weight gain (moderate to good: >5g/kg/day) 2.Survival to Day 28

Secondary

MeasureTime frame
1. Clinical outcome : a.Time to diarrhoea resolution (if >3 loose stools/day) b. Time to oedema resolution c. Time to return of appetite d. Time to nutritional rehabilitation

Countries

Uganda

Contacts

Public ContactJSO Obbo

The Chairman MRRH-REC

stephen.obbo@gmail.com+256772437407

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026