Chronic primary functional constipation Digestive System
Conditions
Interventions
The subjects recruited in the present clinical study have been randomized into the following experimental groups:
GROUP 1 - subjects who received the dietary supplement (TREATMENT A) containing resis
Sponsors
ESSERRE Pharma S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age ranging from 18 to 70 years 2. Able to understand and sign the informed consent 3. Negative HIV test 4. Negative pregnancy test 5. Able to understand and adhere to the protocol requirements 6. Experiencing symptoms of chronic constipation for at least 3 months (with onset at least 6 months prior) 7. Absent or non-dominant, occurring less than once a week, and thus not affected by IBS-C 8. Subjects had to have fewer than three SCBM per week and meet at least one of the following conditions: 8.1. Straining during more than 25% of bowel movements 8.2. Passage of lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements 8.3. Sensation of incomplete evacuation in more than 25% of bowel movements 8.4. Sensation of anorectal obstruction/blockage in more than 25% of bowel movements 8.5. Use of manual maneuvers to facilitate bowel movements in more than 25% of bowel movements 9. Subjects who were not taking and would not take any type of medication throughout the study period
Exclusion criteria
Exclusion criteria: 1. Age less than 18 or greater than 70 years 2. In a state of pregnancy or breastfeeding 3. Abdominal pain occurring at least once a week (subjects with IBS) 4. Subjects with organic intestinal diseases 5. Subjects with a history of gastrointestinal surgery 6. Subjects with gastroesophageal reflux 7. Subjects with Parkinson's disease or Alzheimer's disease 8. Subjects using opioid medications or other drugs with a significant impact on intestinal function (e.g., antidepressants, aluminum-containing antacids), subjects who are currently taking or have taken antibiotics within the past four weeks, or within the past six months depending on the intensity and duration of the antibiotic treatment, and subjects taking medications for other conditions 9. Subjects who abuse alcohol, drugs, caffeine, or theine 10. Subjects with cognitive impairments that may hinder their ability to respond to questionnaires 11. Subjects with a known allergy to the ingredients of the experimental products (active or placebo) 12. Subjects with acquired immunodeficiency syndrome (AIDS) due to HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of the average number of spontaneous complete bowel movements (SCBM) per week in the preceding month as reported by the subject during and recorded in the Bowel Function Diary throughout the study period. The use of the diary is recommended by EMA guidelines as it helps avoid “recall bias” that may occur during visits. SCBM per week in the preceding month: [Time frame: T0 (baseline), T1 (28 days of treatment)]. Bowel Function Diary: [Time frame: the diary was completed daily throughout the entire study duration (28-day run-in period and 28-day treatment period). The average values of spontaneous complete bowel movements (SCBM) per week recorded in the diary during the run-in period and the treatment period were compared in the statistical analysis.]. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stool consistency, which, in addition to the frequency of SCBM, is a valid indicator of functional constipation. EVALUATION METHODS: Bristol Stool Form Scale- BSFS , a validated tool that assesses stool consistency across a spectrum of seven types. Stool types 1 and 2 indicate hard or lumpy stools, while stool types 6 and 7 are indicative of soft or watery stools. Stools characteristic of individuals with constipation are types 1 or 2. Stool consistency was reported by the subjects during visits and recorded in the Bowel Function Diary throughout the study period. [Time frame: T0 (baseline), T1 (28 days of treatment)]. 2. Frequency of symptoms characteristic of constipated individuals (such as bloating and abdominal distension, feeling of heaviness, abdominal pain, and flatulence) which were reported by the subjects during visits and recorded in the Bowel Function Diary throughout the study period. EVALUATION METHODS: Bowel Function diary – BF diary. The diary consisted of: o Sections that the subject was required to complete at the time of bowel movements (date and time, BSFS), and o Sections that the subject was required to complete daily, regardless of the occurrence of an SCBM, including: - Assessment of symptoms characteristic of constipation (bloating and abdominal distension, feeling of heaviness, abdominal pain, flatulence), using a 5-point Likert scale (0 no discomfort – 5 maximum discomfort), - Use of any “salvage treatment” - Daily recording of fluid intake [Time frame: The diary was completed daily for the entire duration of the study]. 3. Use of any “salvage treatment”. EVALUATION METHODS: Recording in the Bowel Function diary – BF diary. Subjects were required to record any use of "salvage treatment" (medications or other laxatives, including dietary supplements, enemas, or suppositories) in the diary to improve bowel function. The use of such treatments did not directly lead to the exclusion of the subject from the study or the discontin | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed