PACTR201805003381361
Completed
未知
Modifying Intestinal Integrity and MicroBiome in severe Malnutrition with LEgume-based feeds [MIMBLE Study]: A Pilot Study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Nutritional, Metabolic, Endocrine
- Sponsor
- Imperial College London
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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 \< 9months) or coma (inability to localise a painful stimulus) after correction of hypoglycaemia if present.
- •¿Shock: two or more of capillary refill time \> 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
Outcomes
Primary Outcomes
Not specified
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