Probiotic safety check: will a daily capsule cause stomach trouble?
NCT ID NCT07165457
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study will give 20 healthy adults a probiotic capsule every day for 15 days to see if it causes any stomach or other side effects. Participants will fill out questionnaires about their symptoms. The goal is simply to check safety, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- probiotic capsule
- What could go wrong
- This is a very small, early safety study with only 20 healthy participants. It does not test any health benefit, so even if it shows no side effects, it won't prove the probiotic helps with any condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2025
An estimate. Start dates often move.
- Expected to finish
-
Oct 2025
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy men and women aged between 18 and 70 years. * Stable body weight (±5%) during the three months prior to study initiation. * Physical examination and vital signs within normal limits or clinically irrelevant for the study. * Subjects must be able to understand and willing to sign the informed consent form, and comply with all study procedures and requirements. * Ongoing pharmacological/hormonal treatment will be permitted provided it does not affect the parameters under investigation and the dosage has been stable for at least three months prior to study initiation. * Willingness to undergo all study procedures, including daily consumption of one probiotic capsule during the intervention. * Availability in terms of time and location to attend the two scheduled in-person clinical evaluation sessions. Exclusion Criteria: * Volunteers undergoing pharmacological treatment with unstable dosing (less than 3 months prior to study initiation) will be excluded, particularly if treatments: * Affect gastrointestinal function. * Include chronically prescribed stomach protectants. * Subjects with significant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc. * Subjects who have undergone surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or bariatric surgery. * Presence of systemic intestinal, hepatic, or renal diseases, such as uncontrolled thyroid disorders, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (non-alcoholic fatty liver disease will not be excluded). * Alcohol consumption exceeding the sex-specific limits (\>14 units/week for women, \>20 units/week for men). * Pregnancy, lactation, or plans to become pregnant during the study period. * Use of nutritional supplements that may affect study outcomes (e.g., weight-loss supplements, newly initiated fiber supplements, probiotics, postbiotics, etc.). * Subjects with any type of cancer currently undergoing treatment, or with less than five years since cancer remission. * Known allergy to any component of the investigational product. * Presence of cognitive and/or psychological impairments. * Anticipated poor compliance or, in the investigator's opinion, difficulty adhering to study procedures. * Participation in any weight loss or body composition modification treatments. * Use of antibiotics within 15 days prior to the baseline visit.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adverse effects are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Center for Nutrition Research
Pamplona, Navarre, 31008, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a chewable postbiotic tablet keep plaque and gum inflammation at bay?
- Can a new oral drug safely help older adults manage weight?
- Can a protein powder with creatine and fiber boost everyday Well-Being?
- Green tech or hidden stress? bus Drivers' hearts monitored behind the wheel
- Shout it out: can growls and screams raise pain tolerance?
- Scientists probe why brain stimulation works for some and not others