Transfer of healthy gut flora for restoration of intestinal microbiota via enema (THRIVE) for severe acute malnutrition: A pilot study evaluating microbial engraftment, safety and nutritional outcomes

OpenBiome0 个研究点目标入组 20 人开始时间: 2017年11月30日最近更新: 2023年5月29日

试验速览

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•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.

•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

发起方

OpenBiome