Clinical trial NCT06722404: Synbiotics for the Management of Malnutrition (Children)
Official title: Effect of Synbiotics on Hematological Indices of Malnourished Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All children were initially fed F-75 (75 kcal/ 100mL) therapeutic milk (Phase I) and then progressed to F-100 (100 kcal/ 100mL) (Phase II) and Plumpy'nuts (F-100 in spread form with iron fortification) (Phase III) with follow-up for 48 days. Synbiotics treatments were given from the onset of F-75 till the child progressed.The control group received standard therapeutic foods (F-75, F-100 and Plumpy'nuts), whereas the intervention group received therapeutic foods plus synbiotics containing Oligomate that was fortified in F75 at the rate of 7.5 g/L containing 4.1 g/L GOS for 1 g/100 kcal dose and at the rate of 11.5 g/L containing 6.1 g/L GOS for 1.5 g/100 kcal dose while in F100 and Plumpy'nuts it was fortified at the rate of 10 g/L containing 5.5 g/L GOS for 1 g/100 kcal dose
Primary purpose: TREATMENT

Brief summary: In this study, dose related effect of synbiotics on the blood indices of severely acute malnourished (SAM) children (6-59 months) was carried out in hospitalized setting. Fifty SAM children were enrolled in a double-blind, randomized design.

Detailed description: The study was done at Nutrition Rehabilitation Unit (NRU), Department of Social \& Preventive Pediatrics, Mayo Hospital, Lahore, Pakistan, a Tertiary Care large urban teaching and referral hospital and was approved by human ethics Institutional Review Board (IRB) .Galacto-oligosaccharides (Oligomate) as prebiotics were procured from Yakult Pharmaceutical Industry, Japan and Resiton (lactobacillus paracasei subsp. paracasei) as probiotics were procured from MakNsons Pharmaceutical Industry, Italy. In the present study we enrolled 50 severely acute malnourished (SAM) in patients of 6-59 months of age while follow-up treatment was given at the out-patient department. We define SAM as weight-for height of less than 70% of the median, nutritional edema (Kwashiorkor), or both, mid-upper arm circumference (MUAC) of less than 11.5cm. Anthropometry protocols were followed by research standards

Eligibility criteria: Inclusion Criteria:

* In the present study we enrolled 50 severely acute malnourished (SAM) patients of 6-59 months of age while follow-up treatment was given at the out-patient department.

  * Patients having weight-for-height of less than 70% of the median, nutritional edema (Kwashiorkor), or both,
  * mid-upper arm circumference (MUAC) of less than 11.5cm

Exclusion Criteria:

* Participant taking other supplements or enrolled in other studies

Primary outcomes:
measure: Weight
timeFrame: 48 days
measure: Number of Stools
timeFrame: 48 days
Secondary outcomes:
measure: Complete blood count (CBC)
timeFrame: 48 days
measure: Serum albumin levels
timeFrame: 48 days
measure: serum electrolytes
timeFrame: 48 days
measure: ESR determination
timeFrame: 48 days
measure: SGPT/ ALT
timeFrame: 48 days
measure: SGOT/ AST
timeFrame: 48 days
measure: Alkaline Phosphatase
timeFrame: 48 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Nutrition Rehabilitation Unit (NRU), Department of Social & Preventive Pediatrics, Mayo Hospital,
state: Punjab
Study officials:
affiliation: University of Veterinary and Animal Sciences,Lahore
name: Habib Ur Rehman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basu S, Chatterjee M, Ganguly S, Chandra PK. Effect of Lactobacillus rhamnosus GG in persistent diarrhea in Indian children: a randomized controlled trial. J Clin Gastroenterol. 2007 Sep;41(8):756-60. doi: 10.1097/01.mcg.0000248009.47526.ea.