Pharmacy and Poisons Board
Protocol No: ECCT/25/11/04 Date of Protocol: 18-06-2025
Study Title:

A Phase 3, randomized, double-blind, placebo-controlled trial to evaluate the effect of Bifidobacterium longum subsp. infantis DSM33361(Bifin02) administered together with Lacticaseibacillus rhamnosus GG DSM33156 (LGG®) versus placebo on weight gain in underweight infants
Study Objectives:

Broad Objective:

1.To evaluate the change in weight (standardized for age) of infants receiving Bifin02 and   LGG® vs placebo     

Specific Objectives:

1.     To evaluate the change in weight of infants receiving Bifin02 and LGG® vs

Placebo.

2.     To estimate the trial intervention response over time associated with Bifin02 and LGG® vs placebo.

3.     To assess the proportion of infants who achieve a specified change in WAZ from baseline to Day 56 in infants receiving Bifin02 and LGG® vs placebo.

4.     To assess the proportion of infants who achieve a specified WAZ at Day 56 in infants receiving Bifin02 and LGG® vs placebo.

5.     To assess the rehospitalization rate of infants receiving Bifin02 and LGG® vs placebo.
Laymans Summary:

General Purpose and Nature of the Study (in non-technical language):
This study is testing whether giving two probiotic supplements (Bifin02 and LGG®) to underweight infants helps them gain more weight compared to a placebo (a harmless, inactive powder). The goal is to see if these probiotics improve their growth, gut health, and overall recovery.

Study Methods (in simple terms):

  • Participants: 200-400 underweight infants aged 1 to 4 months from Kenya and Zimbabwe.
  • Groups: Infants are randomly placed into two groups—one gets the probiotic supplements, and the other gets a placebo.
  • How it’s given: The powders are mixed with breastmilk (or safe water) and fed once daily for 28 days.
  • Timeline: Each infant is followed for about 3 months.
  • Measurements: Researchers track weight, growth (e.g., arm and head size), hospital readmissions, stool and blood samples, and any side effects.
  • Main Goal: To see if infants taking the probiotics gain more weight for their age after 56 days.
  • Other Goals: To look at longer-term effects (up to 90 days), gut health, safety, and how cost-effective the treatment could be for healthcare systems.
Abstract of Study:

Broad Objective:

1.To evaluate the change in weight (standardized for age) of infants receiving Bifin02 and   LGG® vs placebo     

Specific Objectives:

1.     To evaluate the change in weight of infants receiving Bifin02 and LGG® vs

Placebo.

2.     To estimate the trial intervention response over time associated with Bifin02 and LGG® vs placebo.

3.     To assess the proportion of infants who achieve a specified change in WAZ from baseline to Day 56 in infants receiving Bifin02 and LGG® vs placebo.

4.     To assess the proportion of infants who achieve a specified WAZ at Day 56 in infants receiving Bifin02 and LGG® vs placebo.

5.     To assess the rehospitalization rate of infants receiving Bifin02 and LGG® vs placebo.

Study population: Infants

Number of participants to be engaged: 200 to 400 participants. Locally we intend to enroll 60 Participants.

 

Describe the main study procedures:

In this trial, visits will be comprised of both clinic visits and home visits. Home visits and all assessments during these visits will be performed by trained trial team staff. Note that visits designated as home visits in the SoA may also be performed at the trial clinic if preferred. Screening procedures will be conducted after informed consent is obtained and within 14 days before the expected randomization date (Day 1). If informed consent and screening activities are conducted on the same day as randomization (Day 1), assessments should not be duplicated. All screening evaluations must be completed and reviewed to confirm that potential participants meet all eligibility criteria. The Investigator will maintain a screening log to record details of all participants screened and to confirm eligibility or record reasons for screening failure, as applicable. On Day 1, after all eligibility criteria are verified, eligible participants will be randomized.

Participants must have completed any prescribed antibiotic regimens and be discharged from the hospital prior to randomization (Day 1). Procedures conducted as part of the participant’s routine clinical management (e.g., procedures while hospitalized) and obtained before the ICF is signed, may be utilized for screening or baseline purposes provided the procedures met the protocol-specified criteria and were performed within the time frame defined in the SoA . Adherence to the trial design requirements, including those specified in the SoA is essential and required for trial conduct. Immediate safety concerns should be discussed with the Sponsor immediately upon occurrence or awareness to determine if the participant should continue or discontinue trial intervention. Trial procedures and their timing are summarized in the SoA . Protocol waivers or exemptions are not allowed.

Informed Consent will be Written and there is no Assent form