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Comparative Efficacy of Synbiotics Enhanced RUTF versus RUTF Alone in Treating Children with Severe Acute Malnutrition (SAM)

Comparative Efficacy of Synbiotics Enhanced RUTF versus RUTF Alone in Treating Children with Severe Acute Malnutrition (SAM)

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251127011
Enrollment
228
Registered
2025-11-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Malnutrition SAM, RUTF, MUAC, Synbiotics

Interventions

synbiotics will be given along with RUTF at dose of half sachet twice a day in children from 6 months to 59 months of age.,The number of RUTF sachets will be determined according to weight as per WHO
SYNBIOTICS+RUTF,RUTF alone

Sponsors

University Of Child Health sciences lahore
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 59 Months

Inclusion criteria

Inclusion criteria: 1. Children with either gender aged 6-59 months with grade 1-2 bilateral pitting oedema and a weight for height Z-Score of -3 or MUAC of < 11.5 cm who are otherwise clinically healthy aware and with a decent appetite are classified as children with severe acute malnutrition by WHO will be included in this study. 2. Informed and written consent will be taken from parents/guardians of children.

Exclusion criteria

Exclusion criteria: 1. Children with any complications due to SAM mentioned below will be excluded from trial. 2. Acute lower respiratory tract infection with respiratory rate > 50 breaths per min, chest in drawing, wheezing or stridor. 3. High pyrexia or hypothermia i.e. <35 C or >39 C, severe pitting oedema grade 3 and severe hypoglycaemia i.e. <3 mmol/L by heal prick test method using a Dextrostix reagent strip. 4. Children suffering from uncontrolled systemic infections, cerebral palsy or mental health problems. 5. Children who look lazy, apathic, and unconscious or had seizures were excluded from study trial and referred to stabilization centre for treatment. 6. Children with history of recent watery diarrhea associated with signs of severe dehydration i.e. cold peripheries, sunken eyes, absence of urinary output and tears.

Design outcomes

Primary

MeasureTime frame
Mid Upper Arm Circumference (MUAC) 0, 2 and 4 weeks Centimeter / MUAC tape,Weight 0, 2 and 4 weeks kg,Odema 0, 2 and 4 weeks clinically

Secondary

MeasureTime frame
Length of hospital stay over the duration of study days,incidence of any illness over the duration of study episodes of illness,Defaulter over the duration of study Non-compliance to treatment or intervention

Countries

Pakistan

Contacts

Public ContactDr. Hafiza Yaqoob

University of Child Health Sciences The Children's Hospital Lahore

zarkayaqoob@gmail.com092334001706

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026