Synbiotics for the Management of Malnutrition (Children)

University of Veterinary and Animal Sciences, Lahore - Pakistan

Status: Completed

Conditions: Severe Acute Malnutrition

Treatments: Combination Product: Therapeutic foods plus Synbiotics; Dietary Supplement: Standard therapeutic foods

Study type: Interventional

Funder types: Other

Identifiers

NCT06722404

PIN No. 085-14090-AV5-176 (Other Grant/Funding Number)

BeSt 44/ 17

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

standard therapeutic food group

Active Comparator group

Description:

The control group received standard therapeutic foods (F-75, F-100 and Plumpy'nuts)

Treatment:

Dietary Supplement: Standard therapeutic foods

therapeutic foods plus synbiotics group

Experimental group

Description:

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 and at the rate of 15 g/L containing 8.25 g/L GOS for 1.5 g/100 kcal dose and Resiton (Lactobacillus paracasei sbsp. paracasei) 3 billion cfu/day and 6 billion cfu/day that were mixed in different combinations.

Treatment:

Combination Product: Therapeutic foods plus Synbiotics