HealthyNCT05207839
Impact of Galacto-Oligosaccharides on Adult Microbiome
A study testing Milk powder in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial effects on the microbiome of GOS. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Milk powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Oct 2021to 9 Dec 2021
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-55 years,
- Healthy participants, both male and female
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2
- Able to understand and to sign a written informed consent prior to study enrolment
Who cannot join
- Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation,
- Known food allergy and intolerance e.g. lactose intolerance,
- Habitually, have < 5 spontaneous bowel movements on average per week,
- Chronic or recurrent diarrhoea with spontaneous bowel movements > 2 per day
- Prior gastrointestinal surgery (apart from appendectomy or herniotomy),
- Received systemic antiviral/antibacterial/antifungal therapy during the 3 months prior to study enrolment,
Show all 16Show fewer
- Medications or supplements that are known to alter gut function or microflora i.e. acid antisecretory drugs, pre-/probiotics, laxative during the 4 weeks prior to study enrolment,
- Anti-hyperlipidaemic, antihypertensive medications and/or anticoagulant agents,
- Currently participating in another interventional clinical trial or research project,
- Alcohol intake > 2 servings per day; specifically, a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Or other chronic substance abuse,
- Changing diet patterns due to travelling and staying abroad for more than two weeks (Asia, Africa, or Latin America) during the two months prior to study enrolment,
- Food restrictions such as vegan, vegetarian, ketogenic, low carb, paleo, raw diets, caloric restrictive diets,
- Artificially sweetened beverage intake >1000 ml/ per day,
- Female participants will be excluded if they are pregnant, have given birth in the last 6 months, or are lactating,
- Subject having a hierarchical or family link with the research team members,
- Occurrence of fever episodes, infection, or vaccination during 14 days before the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind Trial Evaluating the Impact of the Consumption of GOS (Galacto Oligosacharides) on the Adult Microbiome
The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial effects on the microbiome of GOS.
- Conditions
- Healthy
- Being tested
- Milk powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk powderDietary supplement
one sachet per day dissolved in 200 ml of water
| Study group | Role | What they receive |
|---|---|---|
| Milk powder without GOS | Placebo comparator | Not described Receives: Dietary Supplement: Milk powder |
| Milk powder with GOS | Active comparator | Not described Receives: Dietary Supplement: Milk powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Bifidobacteria in the stools
Measured by Next Generation Sequencing (NGS)
Measured: Throughout 14 days of product intake
Secondary outcomes (4)
Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Score ranging from 0 to 100 (higher scores indicate better health status).
Measured: Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the plasma
The SFCA are measured in the plasma using Liquid Chromatography with tandem mass spectrometry (LC-MSMS)
Measured: Throughout 14 days of product intake
Gastrointestinal Symptom Rating Scale (GSRS)
Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.
Measured: Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the stool
Measured using Gas Chromatography (GC)
Measured: Throughout 14 days of product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start27 Oct 2021
- Primary completion8 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207839
- Sponsor's protocol ID
- 2106NRC1
- Status last verified
- May 2022
- First submitted
- 14 Oct 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegwald L, Cherta-Murillo A, Christen S, Boulange CL, Chou CJ, Foata F, Lahiry A, Frezal A, Giner MP, Godin JP, Sakwinska O. The Impact of Low-Lactose, High Galacto-Oligosaccharides Milk on Gut Microbiome and Plasma Metabolome in Healthy Adults: A Randomized, Double-Blind, Controlled Clinical Trial Complemented by Ex Vivo Experiments. Curr Dev Nutr. 2025 Jul 24;9(9):107506. doi: 10.1016/j.cdnut.2025.107506. eCollection 2025 Sep.
PubMed 40909168
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Trial Evaluating the Impact of the Consumption of GOS (Galacto Oligosacharides) on the Adult Microbiome
- ClinicalTrials.gov ID
- NCT05207839
- Acronym / sponsor ID
- 2106NRC1
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial effects on the microbiome of GOS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk powder without GOS | Placebo comparator | Dietary Supplement: Milk powder |
| Milk powder with GOS | Active comparator | Dietary Supplement: Milk powder |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-55 years,
- Healthy participants, both male and female
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2
- Able to understand and to sign a written informed consent prior to study enrolment
Key exclusion criteria (16 listed)
- Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation,
- Known food allergy and intolerance e.g. lactose intolerance,
- Habitually, have < 5 spontaneous bowel movements on average per week,
- Chronic or recurrent diarrhoea with spontaneous bowel movements > 2 per day
- Prior gastrointestinal surgery (apart from appendectomy or herniotomy),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk powderone sachet per day dissolved in 200 ml of water | Dietary supplement | Milk powder with GOS, Milk powder without GOS |
Primary outcome
Proportion of Bifidobacteria in the stools
Time frame: Throughout 14 days of product intake
Measured by Next Generation Sequencing (NGS)
4 secondary outcomes
Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey)
Time frame: Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the plasma
Time frame: Throughout 14 days of product intake
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the stool
Time frame: Throughout 14 days of product intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 40909168Siegwald L, Cherta-Murillo A, Christen S, Boulange CL, Chou CJ, Foata F, Lahiry A, Frezal A, Giner MP, Godin JP, Sakwinska O. The Impact of Low-Lactose, High Galacto-Oligosaccharides Milk on Gut Microbiome and Plasma Metabolome in Healthy Adults: A Randomized, Double-Blind, Controlled Clinical Trial Complemented by Ex Vivo Experiments. Curr Dev Nutr. 2025 Jul 24;9(9):107506. doi: 10.1016/j.cdnut.2025.107506. eCollection 2025 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk powder in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 4 inclusion and 16 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Proportion of Bifidobacteria in the stools (time frame: Throughout 14 days of product intake). 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 NCT05207839, 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 25 May 2022.