Completed PHASE3 INTERVENTIONAL 2-arm NCT03067714

A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy (TEMPO)

A Randomised, Double-blind, Controlled, Parallel-group, Multi-country Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy

Sponsor: Nutricia Research

Conditions Immunity

Interventions Infant formula with added synbiotics Standard infant formula

Updated 12 times since 2017 Last updated: Dec 7, 2021 Started: Mar 30, 2017 Primary completion: Mar 25, 2020 Completion: Mar 25, 2020

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Immunity, this trial is completed. The trial is conducted by Nutricia Research and has accumulated 12 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

12 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2022 — Jul 2024 [monthly]

Completed PHASE3

Status: Unknown Status → Completed
Oct 2021 — Jan 2022 [monthly]

Unknown Status PHASE3

Status: Active Not Recruiting → Unknown Status

▶ Show 7 earlier versions

Jan 2021 — Oct 2021 [monthly]

Active Not Recruiting PHASE3
May 2019 — Jan 2021 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Sep 2018 — May 2019 [monthly]

Recruiting PHASE3
Jun 2018 — Sep 2018 [monthly]

Recruiting PHASE3
Sep 2017 — Jun 2018 [monthly]

Recruiting PHASE3
Jun 2017 — Sep 2017 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
May 2017 — Jun 2017 [monthly]

Not Yet Recruiting PHASE3

First recorded

Mar 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Nutricia Research

Data source: Nutricia Research

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalst, Belgium , Amsterdam, Netherlands , Balassagyarmat, Hungary , Beek, Netherlands , Berlin, Germany , Breda, Netherlands , Brussels, Belgium , Budapest, Hungary , Debrecen, Hungary , Deventer, Netherlands and 39 more locations