Maternal Probiotic Intervention to Improve Gut Health

NCT06196450 | Unknown Phase 2 DMC

• 1 other identifier: PR-22084
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale trials in which birth outcomes and postnatal growth will be key endpoints.

Conditions

Environmental Enteric Dysfunction; Gut Microbiota Dysbiosis

Keywords

probiotic; gut health; GWG; fetal growth; perinatal outcome

Outcome Measures

Primary Outcomes (1)

• Percentage change (mean, unweighted) in a multiple panel of biomarkers between baseline and last sample collected after 56 days of treatment, compared to control group

  Plasma CRP, AGP, sCD14, LBP, CD163, iFABP, and fecal myeloperoxidase, neopterin, calprotectin and lipocalin by ELISA

  56 days

Secondary Outcomes (5)

• Reduction in colonisation

  56 days

• Change in microbiome

  56 days

• Change in untargeted metabolome

  56 days

• Reduction in intestinal permeability

  56 days

• Change in weight gain velocity in the 2nd trimester of pregnancy

  14 weeks

Other Outcomes (17)

• Recovery of useful data from CapScan

  56 days

• Diversity, centroids and distributions of microbial taxa from sequenced CapScan samples

  56 days

• Fetal growth

  6 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Vivomixx also known as VSL#3, Powder (in sachets), weight 4.4g, 450 X 10\^9 cfu of probiotic bacteria per sachet, dose 1 sachet daily for 56 days

Dietary Supplement: Vivomixx

Placebo arm

PLACEBO COMPARATOR

Microcrystalline maltose, Powder (in sachets), weight 4.4g, dose 1 sachet daily for 56 days

Dietary Supplement: Microcrystalline maltose

Interventions

Vivomixx DIETARY_SUPPLEMENT

Vivomixx is a commercially available probiotic mixture consisting of eight probiotic lactic acid bacteria and Bifidobacteria including Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii subspecies bulgaricus, Streptococcus salivarius subspecies thermophiles, Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium infantis.

Intervention arm

Microcrystalline maltose DIETARY_SUPPLEMENT

Microcrystalline maltose as placebo

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older in the first trimester or early second trimester of pregnancy, living in defined geographical areas of Bangladesh (Matlab), Pakistan, Senegal and Zambia, where it can be assumed that environmental enteropathy is universal

You may not qualify if:

• Potential participants will not be enrolled if they:
• have had diarrhea, defined as the passage of three or more loose stools per 24 hours, in the preceding 14 days
• have taken antibiotics or probiotics in the preceding 14 days
• have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days
• have severe pallor (hemoglobin concentration \<8g/dl)
• have any chronic disease, illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy
• have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)
• have the plan to observe fast at any time during the intervention period
• have the plan to leave the study area within the follow-up period
• are included in any other intervention trial
• belong to a household from which another woman is already enrolled in the study
• but may be enrolled if/when these disqualifiers have expired

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Chāndpur, Bangladesh

RECRUITING

Study Officials

• S. M. Tafsir Hasan, MBBS, MS

  Nutrition Research Division, icddr,b

  PRINCIPAL INVESTIGATOR

Central Study Contacts

S. M. Tafsir Hasan, MBBS, MS

CONTACT

(+88 02) 9827001-10; tafsir.hasan@icddrb.org

Tahmeed Ahmed, MBBS, PhD

CONTACT

(+88 02) 9827001-10; tahmeed@icddrb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vivomixx and Placebo (Crystalline maltose)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-site phase II randomised controlled trial (Proof of concept study)

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: January 9, 2024
• Study Start: June 22, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: January 17, 2024

Record last verified: 2023-12

Locations

BA (1)