HealthyROVERNCT05471206
Evaluation of Gastrointestinal pH and Motility After the Consumption of Milk
A study testing Milk and SmartPill intakes in people with Healthy, run by Lactalis at 1 site in France.
Trial summary
This pilot study is designed as a monocentric, open label, interventional, parallel arms, controlled clinical trial. The aim of the study is to assess the gastrointestinal pH and motility after the consumption of milk. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Milk and SmartPill intakes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2022to 15 Feb 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years (limits included),
- BMI between 18.5 and 30 kg/m² (limits included),
- Able and willing to drink 250mL of milk in 5 minutes,
- Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or clinical examination,
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
- Affiliated with a social security scheme,
- For milk intolerant subjects: self-reporting symptoms after drinking milk and drinking less than 150mL of cow's milk (lactose-free milk not included) per week (assessed by the gastrointestinal symptoms questionnaire filled out at V0).
- For milk tolerant subjects: drinking at least 700mL of cow's milk (lactose-free milk not included) per week (assessed by the gastrointestinal symptoms questionnaire filled out at V0).
Who cannot join
- Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble, uncontrolled arterial hypertension or other metabolic disorder,
- Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis, etc.) or disorders found to be inconsistent with the conduct of the study by the investigator,
- Suffering from any obstructive or restrictive respiratory syndrome (COPD, asthma, etc.) that may impact breath test measurements,
- Suffering from a gastro-intestinal pathology (inflammatory bowel disease, Crohn disease, ulcerative colitis, irritable bowel syndrome, celiac disease, gluten hypersensitivity, small intestinal bacterial overgrowth, diverticulitis, polyps, constipation, esophageal motility abnormality, history of gastric bezoar...), or other gastro-intestinal disorders found to be inconsistent with the conduct of the study by the investigator,
- Suffering from any disorder found to be inconsistent with the conduct of the study by the investigator,
- With a history of gastro-intestinal surgery (only appendectomy is accepted),
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- With swallowing problems,
- With a known or suspected allergy to cows' milk protein,
- With a lactose intolerance diagnosed by a positive Lactose Breath Test,
- Pregnant or lactating women or intending to become pregnant during the study,
- Under treatment or dietary supplement which could significantly affect the gut motility and/or interfere with gastric emptying time and/or affect the gut pH during the study according to the investigator or stopped less than 15 days before the V0 visit (examples: NSAIDs, proton pump inhibitors, prokinetics, treatments against diarrhea or constipation, etc.),
- Regular intake of dietary supplements containing prebiotics, probiotics or symbiotics, or stopped less than 3 months before the V0 visit,
- With significant change in food habits or in physical activity in the 3 months before the V0 visit or not agreeing to keep them unchanged throughout the study,
- Weight loss or gain > 5% of body weight in the 6 months before the study,
- With a current diet or stopped less than 3 months before the study,
- With a current eating disorder (anorexia nervosa, bulimia, etc.) according to the investigator,
- Consuming more than 2 standard drinks of alcoholic beverage daily regularly and not agreeing to keep alcohol consumption habits unchanged throughout the study,
- Smoker (electronic cigarette not allowed),
- Consuming illicit drugs,
- Having an implanted or portable electro-mechanical medical device (such as pacemakers, defibrillators, infusion pumps…etc),
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- Impossible to contact in case of emergency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Gastrointestinal pH and Motility by Using the SmartPill® Motility Capsules After the Consumption of Milk in Symptomatic Milk Intolerant and Asymptomatic Subjects
This pilot study is designed as a monocentric, open label, interventional, parallel arms, controlled clinical trial. The aim of the study is to assess the gastrointestinal pH and motility after the consumption of milk.
The clinical study is categorized as an interventional research involving the human person with low risks and constraints (RIPH 2) and which does not assess a health product.
The milk and medical device used in this clinical study are both authorized and already commercialized in France.
- Conditions
- Healthy
- Being tested
- Milk and SmartPill intakes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk and SmartPill intakesOther
During visit V2, the subject will ingest the SmartPill capsule. Then, subjects will drink milk.
| Study group | Role | What they receive |
|---|---|---|
| Milk intolerant volunteers | Experimental | Not described Receives: Other: Milk and SmartPill intakes |
| Milk tolerant volunteers | Active comparator | Not described Receives: Other: Milk and SmartPill intakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in this study is the AUC of pH, defined between 0 and 120 minutes after ingestion of milk, expressed in pH.min.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start24 Nov 2022
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Why it stopped: End of commercialization of the medical devices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lactalis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Mathilde Guerville, Study director, Lactalis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471206
- Sponsor's protocol ID
- 2021-A02653-38
- Acronym
- ROVER
- Status last verified
- Mar 2024
- First submitted
- 11 Jul 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastrointestinal pH and Motility by Using the SmartPill® Motility Capsules After the Consumption of Milk in Symptomatic Milk Intolerant and Asymptomatic Subjects
- ClinicalTrials.gov ID
- NCT05471206
- Acronym / sponsor ID
- ROVER / 2021-A02653-38
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of commercialization of the medical devices
- Enrolment
- 28 participants (actual)
- Lead sponsor
- LactalisIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 22 Jul 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.
This pilot study is designed as a monocentric, open label, interventional, parallel arms, controlled clinical trial. The aim of the study is to assess the gastrointestinal pH and motility after the consumption of milk.
The clinical study is categorized as an interventional research involving the human person with low risks and constraints (RIPH 2) and which does not assess a health product.
The milk and medical device used in this clinical study are both authorized and already commercialized in France.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk intolerant volunteers | Experimental | Other: Milk and SmartPill intakes |
| Milk tolerant volunteers | Active comparator | Other: Milk and SmartPill intakes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18 and 40 years (limits included),
- BMI between 18.5 and 30 kg/m² (limits included),
- Able and willing to drink 250mL of milk in 5 minutes,
- Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or clinical examination,
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
Key exclusion criteria (24 listed)
- Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble, uncontrolled arterial hypertension or other metabolic disorder,
- Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis, etc.) or disorders found to be inconsistent with the conduct of the study by the investigator,
- Suffering from any obstructive or restrictive respiratory syndrome (COPD, asthma, etc.) that may impact breath test measurements,
- Suffering from a gastro-intestinal pathology (inflammatory bowel disease, Crohn disease, ulcerative colitis, irritable bowel syndrome, celiac disease, gluten hypersensitivity, small intestinal bacterial overgrowth, diverticulitis, polyps, constipation, esophageal motility abnormality, history of gastric bezoar...), or other gastro-intestinal disorders found to be inconsistent with the conduct of the study by the investigator,
- Suffering from any disorder found to be inconsistent with the conduct of the study by the investigator,
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 and SmartPill intakesDuring visit V2, the subject will ingest the SmartPill capsule. Then, subjects will drink milk. | Other | Milk intolerant volunteers, Milk tolerant volunteers |
Primary outcome
The primary endpoint in this study is the AUC of pH, defined between 0 and 120 minutes after ingestion of milk, expressed in pH.min.
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: End of commercialization of the medical devices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- 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.
Mathilde Guerville study director
Lactalis
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 and SmartPill intakes in people with Healthy, run by Lactalis at 1 site in France.
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 8 inclusion and 24 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: stopped early, as of the sponsor's last update on 22 Mar 2024. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: End of commercialization of the medical devices). Results are not available in the source record.
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?
The primary endpoint in this study is the AUC of pH, defined between 0 and 120 minutes after ingestion of milk, expressed in pH.min. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2024.