Sulphate-bicarbonate-calcium Water, Body Weight and Gut Microbiota (NCT02154230) | Clinical Trial Compass
WithdrawnNot Applicable
Sulphate-bicarbonate-calcium Water, Body Weight and Gut Microbiota
Stopped: failure to enroll
Italy0Started 2013-11
Plain-language summary
Overweight and obese patients will be recruited and randomly assigned to two groups of intervention. To the first group \[sulphate-bicarbonate-calcium water and low-calorie diet (SW-D)\] will be administered "Acqua Santa di Chianciano"®, associated to a personalized low calorie diet, while the second group \[tap water and low-calorie diet (TW-D)\] will follow the personalized low calorie diet but will be asked to drink the same quantity of tap water, over a 4 week period. Stool samples will be collected and analyzed for changes in gut microbiota composition. Patients' body weight will be recorded at the beginning and at the end of the study.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women with BMI between 29 and 35 kg/m2
* Age between 18 and 65 years
Exclusion Criteria:
* Therapy with antibiotics, bile salts, cholestyramine, laxatives, pre- or probiotics during the last 3 months before enrollment
* Helycobacter Pylori positivity
* Previous cholecystectomy
* Gallbladder disease
* Cholestasis
* Consumption of more than 20 g of alcohol/day
* Inflammatory bowel diseases
* Previous gastrointestinal surgery modifying the anatomy
* Pregnancy or lactating state
* Prescribed hypocaloric diet in the three previous months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.