Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics

Inclusion criteria

• Men or women between 18-65.
• BMI 18.5-39.9 kg/m2
• According to the ROME IV criteria, patients with functional constipation who meet the following conditions for at least the last three months and with symptoms for at least 6 months before diagnosis:

• The presence of two or more of the following criteria:

• Excessive straining at least in 25% of bowel movements.
• Hard stools (types 1-2 on the Bristol scale) at least in 25% of stools.
• Sensation of incomplete evacuation at least in 25% of the stools.
• Sensation of anorectal obstruction or blockage at least in 25% of bowel movements.
• Manual maneuvers to facilitate defecation at least in 25% of stools.
• Less than three complete spontaneous bowel movements per week.
• Diarrhea rarely occurs without the use of laxatives.
• Insufficient criteria for the diagnosis of irritable bowel syndrome.

Or, according to the ROME IV criteria, patients who suffer from constipation type irritable bowel syndrome defined as a syndrome in which there is abdominal pain with at least two of the following three characteristics:

• Related to defecation.
• Associated with change in stool frequency.
• Associated with a change in stool shape or appearance.
• Patients who have signed the informed consent.
• Patients with the ability to understand and carry out the study procedures.
• Women participating in the study must meet one of these two conditions:

• Women without the possibility of becoming pregnant, defined as any woman who has undergone surgical sterilization or is in a postmenopausal state.
• Women with the possibility of becoming pregnant who regularly use a highly effective contraceptive method (i.e., hormonal contraception, intrauterine device, condoms, sterilization of the male partner (vasectomy), or complete sexual abstinence) while participating in the study.

Exclusion criteria

• Minors under 18 or over 65 years of age.
• Patients diagnosed with other chronic diseases ( Parkinson's or other dementias, cerebral palsy, heart attack, tetraplegia, hemiplegia, intellectual disability, multiple sclerosis, amyotrophic lateral sclerosis (ALS), cystic fibrosis, congenital metabolic diseases, eating disorders).
• With previous surgeries in the gastrointestinal tract.
• Patients with scheduled surgical interventions during the study.
• Patient treated with anticoagulants.
• Patients who have used laxative treatment during the 15 days before the start of the study.
• Patients who have been treated with antibiotics in the last month.
• Usual treatment with opioid analgesics.
• Consumption of supplements with probiotics or prebiotics during the last two weeks before inclusion in the study.
• Patients diagnosed or with sufficient criteria for the diagnosis of ulcerative colitis, Crohn's disease, presence of intestinal obstruction or malignant disease in the gastrointestinal tract.
• Participation in another clinical trial with an investigational medication 30 days before the start of the study.
• Pregnant or breastfeeding women.
• Patients with hypersensitivity, allergy or intolerance to any of the components of the food supplements in the study