Effect of Probiotic Intake in Healthy Population
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorClinica Universidad de Navarra, Universidad de Navarra
About this trial
The main objective of this project is to evaluate the absence of adverse gastrointestinal effects following the consumption of a daily probiotic capsule during 15 days.
The secondary objective of this study is to verify the absence of any adverse effects other than gastrointestinal ones following the daily consumption of a probiotic during 15 days in a healthy population.
Specific objectives are:
* To evaluate changes in gastrointestinal health through self-reported questionnaire. * To determine the adherence to probiotic consumption. * To analyse headache, tiredness/fatigue, muscle or joint pain, fever or low-grade fever, chills, allergic reactions, difficulty sleeping, dizziness and general discomfort by General Adverse Effects Questionnaire.
Target sample size is 20 subjects.
Participants will be allocated in one group (experimental group).
Participants will visit nutritional intervention unit at Clinical Investigation Day 1 (day 1) and at Clinical Investigation Day 2 (day 15).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Probiotic group
Dietary supplementDaily consumption of one capsule containing a probiotic for 15 days
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Probiotic groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gastrointestinal symptoms
Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Time frame
Clinical Investigation Day 1 and Clinical Investigation Day 2Secondary outcomes
1
Body weight
Weight of participants will be measured by bioimpedance and reported in kg
Time frame
Clinical Investigation Day 12
Height
Height of participants will be measured by stadiometer and reported in m.
Time frame
Clinical Investigation Day 13
Body mass index
Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2
Time frame
Clinical Investigation Day 14
Adherence to capsule consumption
Adherence will be assessed using the capsule consumption record form.
Time frame
Clinical Investigation Day 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: