Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides

NCT05282485 | Active Not Recruiting DMC

• 2 other identifiers: AAAT8393R01HD105492
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age.
• To evaluate the effects of synbiotics on infectious morbidity and growth from 4 to 48 weeks of age. Secondary Objectives:
• To evaluate the effects of synbiotics on growth from 4 to 72 weeks of age.
• To evaluate the effects of synbiotics on infant neurodevelopment at 48 and 72 weeks of age.
• To evaluate the effects of synbiotics on biological measurements while it is in place from 4 to 24 weeks of age.
• To evaluate the effects of synbiotics on biological measurements from 4 to 48 weeks of age.
• To evaluate the effects of synbiotics on gut microbiome and fecal short chain fatty acids from 4 to 72 weeks of age.
• To investigate feasibility, acceptance, tolerability, and behavioral adherence with the intervention.
• To investigate whether the synbiotics reduces infectious morbidity and improves growth in CHEU relative to CHUU.
• To investigate whether infant gut microbiota composition, maturity and function, and markers of inflammation and HMOs at baseline and over time are associated with morbidity and poor growth in CHEU and CHUU.

Conditions

HIV; Infant Morbidity; Breast Feeding

Keywords

HIV; Infant Morbidity; Infant Growth; Breastmilk; Probiotic; Synbiotic; HIV-exposed Uninfected Infants; B. infantis; Human Milk Oligosaccharides; 2'-Fucosyllactose; Infant neurodevelopment

Outcome Measures

Primary Outcomes (4)

• Proportion of infants with infectious morbidity from 4-24 weeks

  Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms

  4-24 weeks of age

• Infant length for age Z scores (LAZ) from 4-24 weeks

  Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms

  4-24 weeks of age

• Proportion of infants with infectious morbidity from 4-48 weeks

  Infectious morbidity data related to infectious respiratory or gastrointestinal morbidity will be compared between the two arms

  4-48 weeks of age

• Infant length for age Z scores (LAZ) from 4-48 weeks

  Infant anthropometry will be recorded at each visit to calculate infant length for age Z scores (LAZ) will be compared between the two arms

  4-48 weeks of age

Secondary Outcomes (14)

• Infant weight for age (WAZ) and weight for length (WLZ) Z scores from 4-24 weeks

  4-24 weeks of age

• Infant weight for age (WAZ) and weight for length (WLZ) Z scores from 4-48 weeks

  4-48 weeks of age

• Infant length for age (LAZ), weight for age (WAZ) and weight for length (WLZ) Z scores from 4-72 weeks

  4-72 weeks of age

• Infant microbiota-for-age Z scores (MAZ)

  4-72 weeks of age

• Infant microbiota diversity

  4-72 weeks of age

Study Arms (2)

Synbiotic Group

EXPERIMENTAL

A synbiotic combining 2'-Fucosyllactose (2'-FL) human milk oligosaccharides (HMO) with B.infantis (probiotic) will be administered to infants from 4 to 24 weeks of age.

Dietary Supplement: Synbiotic

Placebo Group

PLACEBO COMPARATOR

Maltodextrin will be administered to infants from 4 to 24 weeks of age.

Dietary Supplement: Maltodextrin

Interventions

Synbiotic DIETARY_SUPPLEMENT

Synbiotic (2'-FL HMO + B. infantis probiotics)

Synbiotic Group

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin

Placebo Group

Eligibility Criteria

• Age: 3 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Greater than 18 years of age
• For HIV-exposed uninfected children (CHEU): Mothers living with HIV documented based on medical record and with viral suppression (i.e., \<400 copies/mL viral load) documented at delivery
• For HIV-unexposed uninfected children (CHUU): Mothers without HIV (document HIV-negative test result at delivery or screening)
• Women who initiated breastfeeding of their infant including:
• Women who currently exclusively breastfeed their infants, or
• Women who breastfed their infants for a period but are no longer breastfeeding, or
• Women who are currently breastfeeding their infants in addition to feeding them formula milk or solids
• For women with HIV: Those currently on first-line standard of care antiretroviral therapy that was initiated a minimum of 12 weeks prior to delivery of the infant included in this study
• Participant has a cell phone that can be used for calls and messages
• Agreement to adhere to Lifestyle Considerations throughout study duration
• weeks of age
• Delivered from a singleton pregnancy
• For children of mothers with HIV: At least one HIV diagnostic nucleic acid amplification test prior to enrollment which is negative and no positive test

You may not qualify if:

• Severe maternal or infant illness (e.g., maternal: tuberculosis, major psychiatric or neurological conditions; infant: any congenitally-acquired infections, major congenital anomalies)
• Use of immunomodulatory or immunosuppressive drugs in either mother or child prior to enrollment in the study
• For mothers with HIV: Mothers who are not currently receiving antiretroviral therapy or who are on regimens other than the currently recommended first-line standard of care in South Africa i.e., first-line dolutegravir- or efavirenz-based regimens.
• Children infected with HIV
• Mother or infant currently taking probiotics, prebiotics, or fiber supplements; or on any nutritional supplements (e.g., FM85) that impact the outcomes of interest
• Mother or infant currently taking antibiotics for more than 14 days, excluding preventative therapies
• Known allergic reactions to components of the treatment or placebo
• Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the aims of the study.

Sponsors & Collaborators

• Columbia University: lead
• University of Stellenbosch: collaborator
• University of California, Los Angeles: collaborator
• University of California, San Diego: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Worcester Campus of Stellenbosch University (SU)

Stellenbosch, Western Cape, 7599, South Africa

Location

Related Publications (2)

• Shivakoti R, Laughton B, Shafiq M, Schoeman E, Glashoff RH, Barnabas S, Fry S, Leu CS, Wang S, Bode L, Aldrovandi G, Kuhn L, Slogrove AL. Feasibility Study of a Powder-Based Supplement Intervention for a future Synbiotic Trial in Breastfed Children from South Africa. Res Sq [Preprint]. 2023 May 15:rs.3.rs-2842773. doi: 10.21203/rs.3.rs-2842773/v1.

  PMID: 37293067 DERIVED

• Shivakoti R, Slogrove AL, Laughton B, Shafiq M, Schoeman E, Glashoff RH, Leu CS, Wang S, Bode L, Aldrovandi G, Kuhn L. Mitigating Infectious morbidity and Growth deficits in HIV-exposed uninfected infanTs with human Milk Oligosaccharide (MIGH-T MO): a randomised trial protocol. BMJ Open. 2022 Dec 30;12(12):e069116. doi: 10.1136/bmjopen-2022-069116.

  PMID: 36585139 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Synbiotics; maltodextrin

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rupak Shivakoti, PhD

  Columbia University Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will recruit 144 women living with HIV and their HIV-exposed uninfected children (72 will receive the interventional product and 72 will receive the placebo). All of the women in the study will have breastfed or are currently breastfeeding their children.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 16, 2022
• Study Start: June 2, 2022
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)