Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in the Rehabilitative Phase of Malnutrition (THRIVE)

This is an interventional other trial for Severe Acute Malnutrition focused on measuring SAM, MAM Read More

Participant Inclusion Criteria

Participants eligible to participate in this study must meet the following inclusion criteria:

1. Age 12 to 60 months.

2. Current diagnosis of malnutrition (defined as a WHZ less than -2 according to the WHO 2006 standards or a MUAC less than 125mm) with failure to respond nutritionally, defined as:

   a. A WHZ of less than -2 according or a mid-upper-arm circumference of less than 125 mm i. No medical complications present ii. 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.

   iii. Participant is in the rehabilitation phase of treatment for malnutrition

3. HIV negative

4. Received at last four weeks of optimal WHO treatment for malnutrition:

   1. Micronutrient supplementation (Vitamin A, zinc and iron) as recommended by local guidelines
   2. Nutritional rehabilitation as recommended by local guidelines.
5. Written informed consent obtained by parent or caregiver.

Participant Exclusion Criteria

Participants will not be able to participate if they meet any of the following exclusion criteria:

1. Evidence of current complicated malnutrition defined as any of the following:

   1. Admitted to acute care ward as inpatient
   2. Signs of severe acute infection such as pneumonia, bacteremia, meningitis. Minor infections such as candida dermatitis, pharyngitis, upper respiratory tract infections will be eligible for inclusion at the discretion of the study physician.
   3. One or more WHO Integrated Management of Childhood Illness danger signs.(3)
   4. Failure to pass appetite test.
   5. Presence of known comorbid diseases such as pulmonary Tuberculosis on treatment, cystic fibrosis, type I diabetes mellitus, intestinal malabsorptive syndromes, chronic lung disease, chronic liver disease, chronic renal disease, chronic neurological diseases (e.g. cerebral palsy) or malignancy undergoing active chemotherapy.
   6. Bilateral pitting pedal edema or generalized anasarca
2. Have taken antibiotics in the past seven days before the Day 0 visit or are anticipated to need antibiotics up to seven days before the Day 0 visit.

3. Congenital malformations, syndromic conditions, and congenital metabolic abnormalities (inborn errors of metabolism) that may adversely affect growth and in the view of the clinician, exposes the child to increased risk.

   a. Fetal alcohol syndrome (FAS) is not an exclusion.

4. Presence of bilateral pitting edema Grade 2.

5. Contraindications to rectal catheter enema:

   1. Anorectal malformations
   2. Rectal prolapse
   3. Hirschsprungs disease
   4. Other contraindication to enema.
6. Primary immune deficiencies
7. Acute, persistent or chronic diarrhea.
8. Dysentery
9. Intestinal abnormalities including malformations, Hirschsprungs disease and short bowel syndrome
10. Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines puts the participant at greater risk from MTT