Trial Outcomes & Findings for Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants (NCT NCT05952076)

NCT ID: NCT05952076

Last Updated: 2025-03-04

Results Overview

The Weight-for-Age Z-score (WAZ) is an anthropometric measure used to classify a child's nutritional status. The WAZ measures the number of standard deviations of a child's actual weight from the median weight of children of the same age based on the World Health Organization (WHO) child growth standards (reference population). WAZ of 0 represents the median weight for age in the reference population. WAZ ≥-3 to \<-2 standard deviations below the WHO child growth standards median is considered moderately underweight and WAZ \<-3 is considered severely underweight. Least Squares Mean, 95% Confidence Interval, and p-value was derived from mixed model repeated measures with treatment and visit as factors and baseline WAZ, baseline age (days), and study intervention compliance as covariates. The treatment\*visit interaction terms were included and used to estimate the adjusted mean difference in Change from Baseline in WAZ between Bi-26 and Placebo.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

Baseline (Day 1) to Day 56

Results posted on

2025-03-04

Participant Flow

This was a Phase 3, randomized, double-blind study that evaluated the impact of Bi-26 (strain of Bifidobacterium longum, B. infantis) supplementation on weight gain in underweight infants.

A total of 40 participants were enrolled from 1 country and were randomized 1:1 in experimental and placebo groups.

Participant milestones

Participant milestones
Measure	Bi-26 Supplementation Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo Participants received placebo (maltodextrin) once-daily orally for 28 days.
Overall Study STARTED	20	20
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Bi-26 Supplementation Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo Participants received placebo (maltodextrin) once-daily orally for 28 days.
Overall Study Death	1	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bi-26 Supplementation n=20 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=20 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.	Total n=40 Participants Total of all reporting groups
Age, Continuous	57.6 Days STANDARD_DEVIATION 21.1 • n=5 Participants	66.6 Days STANDARD_DEVIATION 23.6 • n=7 Participants	62.1 Days STANDARD_DEVIATION 22.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 56

Population: Modified Intention to Treat Population comprised of all participants randomly assigned to study intervention, who received any dose, including a partial dose of the study intervention.

Outcome measures

Outcome measures
Measure	Bi-26 Supplementation n=20 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=20 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.
Change From Baseline in Weight-for-age Z Score (WAZ) at Day 56	0.78 Z-score Interval 0.39 to 1.17	0.67 Z-score Interval 0.28 to 1.06

SECONDARY outcome

Timeframe: Baseline (Day 1) to Day 56

Population: Modified Intention to Treat Population.

Weight (grams) was summarized using descriptive statistics. Baseline (Day 1) was defined as the last available value prior to the participant receiving the first dose of the study intervention. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Bi-26 Supplementation n=20 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=20 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.
Change From Baseline in Weight to Day 56	1491.47 Grams Interval 1233.45 to 1749.48	1382.17 Grams Interval 1123.95 to 1640.39

SECONDARY outcome

Timeframe: Baseline (Day 1) to Day 90

Population: Modified Intention to Treat Population

Outcome measures

Outcome measures
Measure	Bi-26 Supplementation n=20 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=20 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.
Change From Baseline in WAZ Over Time Through Day 90	1.09 Z-score Interval 0.7 to 1.48	1.00 Z-score Interval 0.6 to 1.39

SECONDARY outcome

Timeframe: Baseline (Day 1) to Day 56

Population: Per-Protocol (PP) Population comprised of all participants randomly assigned to study intervention, who received the study intervention, have a Day 90 visit, and did not substantially deviate from the protocol procedures.

Outcome measures

Outcome measures
Measure	Bi-26 Supplementation n=16 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=14 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.
Percentage of Participants With a ≥ 0.3, ≥ 0.4, and ≥ 0.5 Change in WAZ From Baseline at Day 56 Increase of >= 0.3 units	87.5 Percentage of participants Interval 64.5 to 97.8	64.3 Percentage of participants Interval 37.6 to 85.6
Percentage of Participants With a ≥ 0.3, ≥ 0.4, and ≥ 0.5 Change in WAZ From Baseline at Day 56 Increase of >= 0.4 units	87.5 Percentage of participants Interval 64.5 to 97.8	64.3 Percentage of participants Interval 37.6 to 85.6
Percentage of Participants With a ≥ 0.3, ≥ 0.4, and ≥ 0.5 Change in WAZ From Baseline at Day 56 Increase of >= 0.5 units	68.8 Percentage of participants Interval 43.7 to 87.5	64.3 Percentage of participants Interval 37.6 to 85.6

SECONDARY outcome

Timeframe: At Day 56

Population: PP Population.

Outcome measures

Outcome measures
Measure	Bi-26 Supplementation n=16 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=14 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.
Percentage of Participants Who Achieved a Score of WAZ > -2 at Day 56	19 Percentage of participants Interval 5.0 to 43.0	14 Percentage of participants Interval 2.5 to 39.7

SECONDARY outcome

Timeframe: Baseline to Day 56

Population: Safety Population.

Hospitalizations are due to acute non-surgical illness. Percentage of participants re-hospitalized at Day 56 has been presented

Outcome measures

Outcome measures
Measure	Bi-26 Supplementation n=20 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=20 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.
Percentage of Participants Re-hospitalized	NA Percentage of participants Data was not available as there were no events reported in Bi-26 supplementation arm that resulted in re-hospitalization.	20 Percentage of participants Interval 5.7 to 43.7

SECONDARY outcome

Timeframe: Up to Day 90

Population: Safety Population.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE is considered treatment emergent if it started on or after the date of first dose of study intervention administration. Serious TEAE is any untoward medical occurrences at any dose of study medication that: results in death; is life threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect and is an important medical event.

Outcome measures

Outcome measures
Measure	Bi-26 Supplementation n=20 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=20 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Any TEAE	8 Participants	16 Participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Any serious TEAE	1 Participants	5 Participants

SECONDARY outcome

Timeframe: At Days 1, 28, 56 and 90

Population: PP Population.

Stool samples were collected at defined time points to analyze the present of B.infantis.

Outcome measures

Outcome measures
Measure	Bi-26 Supplementation n=16 Participants Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=14 Participants Participants received placebo (maltodextrin) once-daily orally for 28 days.
Percentage of Participants With Presence of B. Infantis in Stool Day 1	62.5 Percentage of participants Interval 37.6 to 83.2	50.0 Percentage of participants Interval 25.1 to 74.9
Percentage of Participants With Presence of B. Infantis in Stool Day 28	100.0 Percentage of participants Interval 82.9 to 100.0	57.1 Percentage of participants Interval 31.1 to 80.4
Percentage of Participants With Presence of B. Infantis in Stool Day 56	100.0 Percentage of participants Interval 82.9 to 100.0	57.1 Percentage of participants Interval 31.1 to 80.4
Percentage of Participants With Presence of B. Infantis in Stool Day 90	93.8 Percentage of participants Interval 72.8 to 99.7	57.1 Percentage of participants Interval 31.1 to 80.4

Adverse Events

Bi-26 Supplementation

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Placebo

Serious events: 5 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Bi-26 Supplementation n=20 participants at risk Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=20 participants at risk Participants received placebo (maltodextrin) once-daily orally for 28 days.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
General disorders Pyrexia	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
General disorders Sudden death	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Meningitis	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Otitis media	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Pneumonia	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	10.0% 2/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Pneumonia measles	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
General disorders Death	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.

Other adverse events

Additional Information

Study Director

Gates MRI

Phone: +1 857 702 2108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Bi-26 Supplementation n=20 participants at risk Participants received Bi-26 supplementation once-daily orally for 28 days.	Placebo n=20 participants at risk Participants received placebo (maltodextrin) once-daily orally for 28 days.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Gastrointestinal disorders Abdominal pain	20.0% 4/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	15.0% 3/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Gastrointestinal disorders Vomiting	20.0% 4/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	40.0% 8/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Gastrointestinal disorders Abdominal distension	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	15.0% 3/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
General disorders Pyrexia	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	15.0% 3/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Nasopharyngitis	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	10.0% 2/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Acarodermatitis	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Bronchiolitis	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Conjunctivitis viral	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Influenza	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Measles	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Infections and infestations Upper respiratory tract infection	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	15.0% 3/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.	5.0% 1/20 • Up to 90 Days TEAEs and serious AEs were collected in Safety Population.