The Effect of Natural Carbonated Mineral Water Consumption on Gastrointestinal Transit and on Gut Microbiota in Subjects With Functional Constipation: A Randomized, Placebo-Controlled Pilot Trial

Inclusion Criteria:

• Age between 18 to 70
• Having Functional Constipation diagnosis criteria, according to the Rome IV criteria
• Not using any laxative drug for 3 days before screening visit
• Drinking 1.0 ± 0.5 L of water per day
• Accept and sign the consent

Exclusion Criteria:

• Treatment or disease (current or past) likely to interfere with evaluation of thestudy parameters
• Taking antibiotics in the 3 months preceding the recruitment visit
• Taking supplements and any food enriched or presented containing bacteria or yeastslikely to have an effect on the gastrointestinal tract, particularly on intestinaltransit, digestive comfort, gas production, the occurrence of abdominal pain in the 30days preceding the recruitment visit (these products will also be banned during thestudy period)
• Subject having an alcohol consumption of more than 3 glasses of wine a day, or 2glasses of beer a day, or 1 glass of hard liquor a day
• Subject having a coffee consumption greater than 5 cups per day
• Subject with constipation attributable to an organic or anatomical cause (Hirschsprung's disease, hypothyroidism, mental deficiency, psychiatric illness,neurological abnormalities, history of operation of the colon or anus, colorectalcancer, anemia, etc.)
• Subject with a history of current gastrointestinal pathology or disorder such asduodenal ulcer, chronic colitis, or chronic inflammatory disease of thegastrointestinal tract (Crohn's disease, ulcerative colitis), celiac disease orsyndrome irritable bowel
• Subject having a history of operation of the digestive tract
• Subject having undergone surgery in the two months preceding the recruitment visit
• Subject having undergone bariatric surgery
• History of renal disease (renal insufficiency etc.) or cardiovascular disease (cardiacinsufficiency...), respiratory disease, neural disease
• Having participated in a weight loss program (with a 5-10% weight) loss in the last 3months prior to the recruitment visit
• Body mass index > 35 kg/ m2
• Taking supplements of magnesium, vitamins, or other minerals during the study period
• Intake of other carbonated mineral waters beyond the given water, during the studyperiod.
• Pregnancy
• Participation in another clinical trial during the last 30 days prior to therecruitment visit