Centre for Nutrition Research
Pamplona, Navarre, Spain
NCT Number: NCT06248177
The goal of this randomized clinical trial is to evaluate the effect on the microbiota and the reduction in the number and/or intensity of symptoms of gastrointestinal discomfort of consuming a probiotic or placebo for 6 weeks in adult women and men.
The main questions to answer are:
1. To study changes in the alpha diversity of the microbiota. 2. To evaluate changes in the salivary cortisol.
For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 30 subjects.
Participants will be allocated in two groups for 16 weeks (6 weeks consuming one of the products + 4 weeks wash-out period + 6 weeks consuming the other product).
* Group 1 (n=15): 6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule. * Group 2 (n=15): 6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Pamplona, Navarre, Spain
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.
During the intervention, volunteers will attend 4 visits distributed in two phases of 6 weeks separated by 4 weeks of wash-out period. At the beginning and at the end of each phase there will be a clinical visit. In all visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary and physical activity will be collected.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotic capsules
Placebo capsules
Time frame: Clinical Investigation Days 1, 2, 3 and 4.
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.
Time frame: Clinical Investigation Days 1, 2, 3 and 4 (at wake up in the morning, and at the same time in each Clinical investigation days).
Cortisol levels will be taken by Salivette®- Cortisol kit and analyzed by electrochemiluminescence immunoassay and reported in ug/dL.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Weight of participants will be measured by bioimpedance and reported in kg
Time frame: Clinical Investigation Day 1
Height of participants will be measured by stadiometer and reported in m.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body mass index will be calculated as follows: weight (kg)/ height (cm)2.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body lean mass of participants will be analyzed by bioimpedance and reported in kilograms.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body water mass of participants will be analyzed by bioimpedance and reported in kilograms.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Gastrointestinal symptoms will be registrated through 15 items likert questionnaire; gastrointestinal symptoms rating scale questionnaire.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Dietary intake will be analysed by food frequency questionnaire.
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire (IPAQ).
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Adherence will be assessed using the capsule consumption record form.
Clinica Universidad de Navarra, Universidad de Navarra
Other
Effect of a Probiotic Consumption on Gastrointestinal Symptoms in Adults Men and Women (FLORABIOTIC REFUERZO).
Acronym: FLORABIOTIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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