Transfer of healthy gut flora for restoration of intestinal microbiota via enema (THRIVE) for severe acute malnutritio

Not Applicable

• Conditions: Nutritional, Metabolic, Endocrine; Severe acute malnutrition

• Registration Number: PACTR201712002827168
• Lead Sponsor: OpenBiome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Age 18 to 60 months.
2.Stable SAM defined as:
a.A WHZ of less than ¿3 according to the 2006 WHO Growth Standards or a mid-upper-arm circumference of less than 115 mm
b.No medical complications present
c.Participant is sufficiently alert and successfully passes the appetite test which involves consumption of breastmilk or a ready to use therapeutic food (RUTF) under supervision.
d.Participant is in the rehabilitation phase of treatment for SAM
3.No bilateral pitting pedal edema or generalized anasarca.
4.HIV negative.
5.Optimal WHO treatment for SAM:
oCompleted course of antibiotics as part of standard therapy for SAM within the last 3 months.
oDeworming in the last 3 months.
oMicronutrient supplementation (Vitamin A, zinc and iron) as recommended by local guidelines
oNutritional rehabilitation as recommended by local guidelines
6.Written informed consent obtained by parent or caregiver.

Exclusion Criteria

1.Evidence of current complicated SAM defined as any of the following:
a.Admitted to acute care ward as inpatient
b.Signs of acute infection.
c.One or more WHO Integrated Management of Childhood Illness danger signs.(2)
d.Failure to pass appetite test.
e.Presence of known comorbid diseases such as pulmonary Tuberculosis, cystic fibrosis, type I diabetes mellitus, intestinal malabsorptive syndromes, chronic lung disease, chronic liver disease, chronic renal disease or malignancy undergoing active chemotherapy.
f.Bilateral pitting pedal edema or generalized anasarca
2.Ongoing antibiotic use for indication other than SAM (e.g. infection, HIV prophylaxis).
3.Congenital malformations, syndromic conditions and metabolic abnormalities (inborn errors of metabolism) that may adversely affect growth.
4.Kwashiorkor or marsmic-kwashiorkor.
5.Bilateral pitting edema Grade 2.
6.Contraindications to enema:
a.Anorectal malformations
b.Rectal prolapse
c.Hirschsprungs disease
d.Other contraindication to enema.
7.Primary immune deficiencies
8.Neutropenia
9.Persistent and chronic diarrhea (>7 days of loose or water stools).
10.Dysentery
11.Intestinal abnormalities including malformations, Hirschsprungs disease and short bowel syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified