Nutritional, Metabolic, Endocrine Severe acute malnutrition
Conditions
Interventions
Microbiota Transfer Therapy
Standard of care
Sponsors
OpenBiome
Eligibility
Sex/Gender
All
Inclusion criteria
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: o Completed course of antibiotics as part of standard therapy for SAM within the last 3 months. o Deworming in the last 3 months. o Micronutrient supplementation (Vitamin A, zinc and iron) as recommended by local guidelines o Nutritional rehabilitation as recommended by local guidelines 6. Written informed consent obtained by parent or caregiver.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Number of participants with an SAE grade 2 or above up | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutritional: Proportion of participants with nutritional recovery. Defined as weight for height z-score (WHZ) ¿ -2, MUAC ¿ 115 mm.;Clinical: Resolution of signs and symptoms of SAM. Clinical signs include diarrhea (¿ 3 loose stools in the last 24 hours), vomiting, fever (axillary temperature > 38.5¿C), cough, tachypnea (average of two measures; defined as respiratory rate of > 40 breaths per minute for children 18-60 months of age).;Microbiological: Assess engraftment of donor microbial communities in recipients through taxonomic characterization of donor and recipient microbiota pre- and post-MTT using both 16S rRNA and metagenomic techniques.;Translational: Assess the capacity for MTT to normalize biomarkers correlated with disease status and mortality in SAM. Stool biomarkers include Myeloperoxidase and Aplha-1-Antitrypsin. Serological biomarkers include CRP, serum calprotectin (S100 A8/9), endotoxin assay (Hek-Blue) and leptin. | — |
Countries
South Africa
Contacts
Public ContactMajdi Osman
Outcome results
None listed