Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Bangladesh, Pakistan, Senegal and Zambia

NCT05608928 | Unknown Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: NHRA000014/18/07/2022
• Study Type: interventional
• Target: 76
• Locations: 4 countries
• Sites: 4

Brief Summary

This trial will determine if a well-established probiotic, Vivomixx, can modulate the maternal microbiota and ameliorate the 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 phase 2 trial in which birth outcomes and postnatal growth will be key endpoints.

Conditions

Environmental Enteropathy

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 by ELISA Plasma AGP by ELISA Plasma sCD14 by ELISA Plasma LBP by ELISA Plasma iFABP by ELISA Plasma CD163 by ELISA Faecal MPO by ELISA Faecal neopterin by ELISA Faecal calprotectin by ELISA Faecal lipocalin by ELISA

  2 months

Secondary Outcomes (6)

• Reduction in colonisation

  2 Months

• Change in microbiome

  2 months

• Reduction in LR ratio in Vivomixx compared to placebo groups

  2 months

• Change in metabolome

  2 months

• Weight gain velocity in the 2nd trimester of pregnancy

  weekly for 56 days

Other Outcomes (1)

• Tertiary outcome:Recovery of useful data from CapScan

  2 months

Study Arms (2)

Vivomixx

EXPERIMENTAL

Vivomixx also known as VSL#3 is a commercial 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. VSL#3 contributes to balancing the gut and vaginal microbiota and is used as a food supplement for management of diseases like irritable bowel syndrome, ulcerative colitis or ileal pouch.

Dietary Supplement: VSL#3; Device: Capscan device; Combination Product: Placebo

Capscan device

EXPERIMENTAL

The CapScan device is a short-term single-use class IIa ingestible medical device that collects fluids from the gastrointestinal ("GI") tract and is collected in the stool. GI samples are then extracted from the device and analyzed outside the body.

Dietary Supplement: VSL#3; Device: Capscan device; Combination Product: Placebo

Interventions

VSL#3 DIETARY_SUPPLEMENT

VSL#3 is a commercial 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. VSL#3 contributes to balancing the gut and vaginal microbiota and is used as a food supplement for management of diseases like irritable bowel syndrome, ulcerative colitis or ileal pouch.

Also known as: Vivomixx

Capscan device; Vivomixx

Capscan device DEVICE

The CapScan device is a short-term single-use class IIa ingestible medical device that collects fluids from the gastrointestinal ("GI") tract and is collected in the stool. GI samples are then extracted from the device and analyzed outside the body.

Also known as: capstan

Capscan device; Vivomixx

Placebo COMBINATION_PRODUCT

microcrystalline cellulose

Capscan device; Vivomixx

Eligibility Criteria

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

You may qualify if:

• Women over the age of 18 years in the second trimester of pregnancy, living in defined geographical areas of Bangladesh, 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 diarrhoea, 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 non-steroidal anti-inflammatory drugs in the preceding 14 days;
• have haemoglobin concentration \<8g/dl;
• have any illness which in the opinion of the investigator will complicate 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 a plan to leave the study area within the follow-up period;
• but may be enrolled if/when these disqualifiers have expired.

Sponsors & Collaborators

• Tropical Gastroenterology & Nutrition Group (TROPGAN): lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (4)

Icddr,B

Dhaka, 1000, Bangladesh

Location

Aga Khan University, icddr,b

Karachi, Sindh, 75700, Pakistan

Location

Institut pasteur de dakar

Dakar, 10200, Senegal

Location

TROPGAN

Lusaka, 10101, Zambia

Location

Related Publications (4)

• Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

  PMID: 23746772 BACKGROUND

• Olofin I, McDonald CM, Ezzati M, Flaxman S, Black RE, Fawzi WW, Caulfield LE, Danaei G; Nutrition Impact Model Study (anthropometry cohort pooling). Associations of suboptimal growth with all-cause and cause-specific mortality in children under five years: a pooled analysis of ten prospective studies. PLoS One. 2013 May 29;8(5):e64636. doi: 10.1371/journal.pone.0064636. Print 2013.

  PMID: 23734210 BACKGROUND

• Prendergast AJ, Humphrey JH. The stunting syndrome in developing countries. Paediatr Int Child Health. 2014 Nov;34(4):250-65. doi: 10.1179/2046905514Y.0000000158. Epub 2014 Oct 13.

  PMID: 25310000 BACKGROUND

• de Onis M, Branca F. Childhood stunting: a global perspective. Matern Child Nutr. 2016 May;12 Suppl 1(Suppl 1):12-26. doi: 10.1111/mcn.12231.

  PMID: 27187907 RESULT

Study Officials

• Paul Kelly, Dr

  Tropical Gastroenterology & Nutrition Group (TROPGAN)

  PRINCIPAL INVESTIGATOR

• Yakhya Dieye, Dr

  Institut Pasteur de Dakar

  PRINCIPAL INVESTIGATOR

• Fyezah Jehan, Dr

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Asad Ali, Dr

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Tahmeed Ahmed, Dr

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miyoba Chipunza, MBA

CONTACT

973372863; miyoba@tropgan.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Vivomixx and placebo drug
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-site phase II randomised controlled trial

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: December 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

BA (1); PA (1); SE (1); ZA (1)