Synbiotics for the Management of Malnutrition (Children)

NCT06722404 | Completed DMC

• 2 other identifiers: BeSt 44/ 17PIN No. 085-14090-AV5-176
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (2)

• Weight

  weight change observed in patients

  48 days

• Number of Stools

  Number of stools per day

  48 days

Secondary Outcomes (7)

• Complete blood count (CBC)

  48 days

• Serum albumin levels

  48 days

• serum electrolytes

  48 days

• ESR determination

  48 days

• SGPT/ ALT

  48 days

Study Arms (2)

standard therapeutic food group

ACTIVE COMPARATOR

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

Dietary Supplement: Standard therapeutic foods

therapeutic foods plus synbiotics group

EXPERIMENTAL

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.

Combination Product: Therapeutic foods plus Synbiotics

Interventions

Standard therapeutic foods DIETARY_SUPPLEMENT

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

standard therapeutic food group

Therapeutic foods plus Synbiotics COMBINATION_PRODUCT

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.

therapeutic foods plus synbiotics group

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Participant taking other supplements or enrolled in other studies

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

Nutrition Rehabilitation Unit (NRU), Department of Social & Preventive Pediatrics, Mayo Hospital,

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 17700424 BACKGROUND

MeSH Terms

Conditions

Severe Acute Malnutrition

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Habib Ur Rehman

  University of Veterinary and Animal Sciences,Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: March 7, 2017
• Primary Completion: August 11, 2017
• Study Completion: October 19, 2017
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)