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Clinical Trials/PACTR201805003381361
PACTR201805003381361
Completed
未知

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

Imperial College London0 sites90 target enrollmentMay 12, 2018

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.

Registry
who.int
Start Date
May 12, 2018
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

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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