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ImmunityPhase 3TEMPONCT03067714

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

A Phase 3 study testing Infant formula with added synbiotics and Standard infant formula in people with Immunity, run by Nutricia Research at 59 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority. It is generally acknowledged that breastfeeding is one of the main pillars in allergy prevention. Read more about this study

Who is it for?
Ages Up to 16 weeksHealthy volunteers can take part
Conditions the study is for
Immunity
What is being tested?
Infant formula with added synbiotics and Standard infant formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
855 participants
Where
59 sitesin 13 countries
Study dates
30 Mar 2017to 25 Mar 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks) at high risk of developing allergy based on family history of allergy (*1).
  • Infants aged ≤ 16 weeks (max. 16 weeks + 0 days), preferably as soon as possible after birth.
  • Infants who start formula feeding within 16 weeks of age (infants of mothers who have chosen not to breastfeed or mothers who completely/partially cease breastfeeding before the subject's age of 16 weeks) (*2) OR Infants who are exclusively breastfed and whose mothers have the intention to exclusively breastfeed at least until their infant is 16 weeks of age (*2,3).
  • Written informed consent from one or both parents (according to local laws) and/or legal guardian.
  • 1 Family history of allergy is defined as at least one first-degree relative (parent or full sibling) with self-reported historically doctor confirmed allergic disease (allergic rhinitis, asthma, food allergy, allergic eczema). In case of a self-reported historically non-doctor confirmed allergic disease, doctor confirmation must be done as part of the screening procedure according to local practice (e.g. skin prick test, IgE measurement).
  • 2 Subjects whose mother intents to switch to formula feeding before the subject's age of 16 weeks but in the end still exclusively breastfeed, will be included in the breastfed reference group. The other way around, subjects whose mother intents to exclusively breastfeed for at least 16 weeks, but in the end decides to switch to formula earlier, will be included in the randomised groups. All these subjects should meet all other in-/exclusion criteria.
  • 3 Exclusive breast feeding. WHO definition: only breast milk and no other liquids or solids except for drops or syrups consisting of vitamins, mineral supplements or medicines [2]. In addition to the WHO definition, in this study water is allowed as well as formula feeding during the first 72 hours of life.

Who cannot join

  • Consumption of any amount of infant formula based on intact protein before randomisation, except from consumption during the first 72 hours of life.
  • Consumption of any amount of infant formula with added probiotics and/or probiotic supplement before randomisation.
  • Existing allergic manifestations (e.g. allergic skin disorders, food allergy) before randomisation according to investigator's clinical assessment.
  • Established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or in infants on a fibre-free diet.
  • Severe congenital abnormalities which could influence the subjects' growth (e.g. cystic fibrosis, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, major congenital heart disease, or any other condition according to investigator's clinical judgement).
  • Severe neonatal illnesses (e.g. respiratory distress syndrome, severe sepsis intraventricular hemorrhage, severe neonatal jaundice, necrotizing enterocolitis, persistent pulmonary hypertension of the newborn, or any other condition which required to be treated with intravenous and/or intramuscular antibiotics).
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  • Known underlying disease predisposing to infection (e.g. HIV, viral hepatitis B, and C, auto-immune diabetes, immune deficiency).
  • Severe renal failure and hepatic failure according to investigator's clinical judgement.
  • Incapability of the parents to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
  • Participation in other studies involving investigational or marketed products concomitantly or within two weeks prior to screening visit.

Trial locations and contacts

59 sites in 13 countries.

59 sites in 13 countries

Slovakia9 sites

  • PEGYS s.r.o.

    Dolný Kubín

  • Juvenalia, s.r.o.

    Dunajská Streda

  • GASTREN, spol. s.r.o.

    Košice

  • PEDMAN s.r.o.

    Martin

  • Univerzitna nemocnica Martin

    Martin

  • Fakultna nemocnica Nitra

    Nitra

  • GASTOL s.r.o.

    Prešov

  • Fakultna nemocnica Trencin

    Trenčín

  • Ambulancia vseobecneho lekara pre deti a dorast

    Zlaté Moravce

Other trials in Slovakia

Hungary8 sites

  • Dr. Kenessey Albert Korhaz-Rendelointezet

    Balassagyarmat

  • Pestszentimrei Gyermekrendelő / Elitance Duo Kft.

    Budapest

  • Rózsavölgyi Gyermekháziorvosi Rendelő / CEBA Egészségügyi Bt.

    Budapest

  • Gyermekorvosi Rendelő

    Debrecen

  • Futurenest Kft.

    Miskolc

  • Prehospital Med Kft

    Miskolc

  • Kanizsai Dorottya Korhaz

    Nagykanizsa

  • Házi Gyermekorvosi Rendelő /Babadoki Kft.

    Szeged

Other trials in Hungary

Spain7 sites

  • Hospital HLA Inmaculada Servicio de Pediatría

    Granada

  • Hospital Universitario Virgen de las Nieves

    Granada

  • Hospital Materno Infantil La Paz

    Madrid

  • Hospital Sant Joan de Deu

    Manresa

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Instituto Hispalense de Pediatría

    Seville

  • Hospital Universitari i Politecnic La Fe

    Valencia

Other trials in Spain

Israel6 sites

  • Hillel Yaffe Medical center

    Hadera

  • Rambam Health Care Campus

    Haifa

  • Meir Medical Center

    Kfar Saba

  • Schneider Children's Medical

    Petah Tikva

  • Kaplan Medical Center

    Rehovot

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Czechia5 sites

  • MUDr. Daniel Drazan, prakticky lekar pro deti a dorost

    Prague

  • MUDr. Jitka Fabianova

    Prague

  • Prakticky lekar pro deti a dorost

    Prague

  • Ustav pro peci o matku a dite

    Prague

  • Nemocnice Strakonice, a.s.

    Strakonice

Other trials in Czechia

Netherlands5 sites

  • VU University Medical Center

    Amsterdam

  • PT&R

    Beek

  • Amphia Ziekenhuis

    Breda, North Brabant, 4819 EV

  • Deventer Ziekenhuis

    Deventer

  • EB UtrechtResearch BV

    Utrecht

Other trials in Netherlands

United Kingdom5 sites

  • Royal London Hospital

    London

  • University College Hospital

    London

  • Central Manchester University Hospitals NHS Foundation Trust

    Manchester

  • The Newcastle Hospitals NHS Foundation Trust

    Newcastle

  • University Hospital Southampton NHS Foundation Trust

    Southampton

Other trials in United Kingdom

Belgium4 sites

  • Algemeen Stedelijk Ziekenhuis

    Aalst

  • Cliniques universitaires Saint-Luc

    Brussels

  • Universitair Ziekenhuis Brussel

    Brussels

  • Centre Hospitalier Régional de Namur

    Namur

Other trials in Belgium

Italy3 sites

  • Ospdale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

    Milan

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia

  • UOC Allergologia, Osp. Pediatrico Bambino Gesù, IRCCS;

    Roma

Other trials in Italy

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Singapore2 sites

  • Kandang Kerbau Women's and Children's Hospital

    Singapore

  • National University Hospital

    Singapore

Other trials in Singapore

Taiwan2 sites

  • China Medical University Hospital

    Taichung

  • LinKou Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

Germany1 site

  • Charité Universitätsmedizin Berlin

    Berlin

Other trials in Germany

About this study

Official title: 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

With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority. It is generally acknowledged that breastfeeding is one of the main pillars in allergy prevention. Infant formulas based on hydrolysed proteins have been developed to be used by infants at increased risk of developing allergy in case a mother is unable or chooses not to breastfeed her infant. It has recently been demonstrated that the gut microbiota composition and microbiota activity of infants receiving an infant formula based on partially hydrolysed proteins, supplemented with oligosaccharides, is more similar to breastfed infants than to infants receiving standard cow's milk formula, demonstrated by increased levels of bifidobacteria. However the interaction between microbial changes impacted by an hypoallergenic concept and its influence on early life immune development should be further explored. The aim of the present study is therefore to investigate the bifidogenic effect of a hypoallergenic formula supplemented with prebiotics and probiotics compared to standard infant formula in infants at increased risk of developing allergic disease. This study will secondary assess the effects of this concept on the development of allergic manifestations up to the age of 12 months, which will be verified in a separate clinical study MAESTRO as primary outcome. Furthermore, the effects on growth and safety will be studied.

Conditions
Immunity
Being tested
Infant formula with added synbiotics, Standard infant formula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infant formula with added synbioticsOther

    Intervention group: Infant Formula / Follow-On formula with partially hydrolysed cow's milk protein supplemented with prebiotics and probiotics.

  • Standard infant formulaOther

    Control group: Standard Infant Formula / Follow-On formula with intact cow's milk protein (only standard ingredients, without addition of pre- and probiotics).

Study groups in NCT03067714
Study groupRoleWhat they receive
Active product: partially hydrolysed formula + synbioticsExperimentalNot described
Receives: Other: Infant formula with added synbiotics
Control product: standard formula (intact protein)Active comparatorNot described
Receives: Other: Standard infant formula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Faecel levels of Bifidobacteria

    Levels of Bifidobacteria at 17 weeks of age - stool sample

    Measured: 17 weeks

Secondary outcomes (2)

  1. Faecal levels of Bifidobacteria and adult-like bacterial cluster

    Levels of Bifidobacteria and adult-like bacterial cluster up to 52 weeks of age - stool sample

    Measured: 52 weeks

  2. IgE-mediated allergic manifestations

    IgE-mediated allergic manifestations up to 52 weeks of age - blood sample

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study start30 Mar 2017
  3. Primary completion25 Mar 2020
  4. Study completion25 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
855 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067714
Sponsor's protocol ID
EBB15BL89847
Acronym
TEMPO
Status last verified
Dec 2021
First submitted
1 Feb 2017
Last updated
8 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Savova MV, Zhu P, Kindt A; TEMPO study team; Wopereis H, Belzer C, Harms AC, Hankemeier T. Fecal metabolome alterations in infants at risk of developing allergies during the first year of life. Metabolomics. 2026 Jul 1;22(4):112. doi: 10.1007/s11306-026-02478-6.

    PubMed 42384241

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infant formula with added synbiotics and Standard infant formula in people with Immunity, run by Nutricia Research at 59 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Slovakia, Hungary, Spain, Israel, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Faecel levels of Bifidobacteria (time frame: 17 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.

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