Chronic constipation K59.0
Conditions
Interventions
Group 1: Intervention group
The complete study lasts 4 weeks (1 week run-in + 3 weeks intervention). During this time, 2 online surveys take place (1st = baseline survey at the end of run-in, 2nd = f
Sponsors
Gottfried Wilhelm Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Persons capable of giving consent, diagnosis of functional constipation and irritable bowel syndrome with predominant constipation (IBS-C) using the Rome IV criteria, BMI 18.5 - <35.0 kg/m², physical active subjects, usual fluid consumption (beverages) at least 1500 mL/day, regulary consumption of fiber (fruits, legumes and/or whole grain)
Exclusion criteria
Exclusion criteria: Medical and health conditions: • Diagnosed medical conditions: chronic diseases of the gastrointestinal tract (e.g. ulcerative colitis, Crohn's disease), non-treated thyroid dysfunction, cancer within the last two years, renal conditions (e.g. renal insufficiency, urinary tract diseases), liver disease (e.g. hepatitis, liver cirrhosis, non-alcoholic fatty liver disease) • Reproductive status: Pregnant, breastfeeding, or intention to become pregnant during the study • Surgery: abdominal surgery within the last 3 months prior to study participation, planned surgeries within the next 3 months • Health status: immobile subjects (e.g. bedridden subjects, wheelchair users) Medication and supplements: • Medication and supplement alterations: changes to medication or supplement intake that are known to cause constipation (e.g. diuretics, antidepressants, antihypertensive drugs) within the past month prior to study participation and during the intervention study • Laxatives: use of laxatives (e.g. bisacodyl-, sodium picosulfate- and makrogol containing drugs) 3 days before study start Dietary and consumption patterns: • Mineral water: consumption of mineral water other than the water provided for the study • Dietary modification: planned or suspected modification of dietary habits within stidy period an shortly before Lifestyle factors: • Physical activity: planned or suspected modification of physical activity habits within the study period • Illicit drug use and medication abuse: current or past-year history • Tobacco/nicotine: important changes in nicotine consumption within the past month prior to study participation and during the study period (e.g. stopping nicotine consumption) Legal and regulatory concerns: • Study participation: simultaneous participation in another clinical study or within the past 2 months prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of defecation (bowel movements) between baseline and the end of the intervention (week 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly: stool consistency at each bowel movement (Bristol stool chart), stool protocol with pain during bowel movement, fluid protocol, use of laxatives, undesirable effects (adverse events) Baseline and final survey: severity of constipation symptoms (PAC-SYM), quality of life (PAC-QoL), nutrition (FFQ), physical activity (EHIS-PAQ), Medication and dietary supplements, smoking behavior Run-in and last week of intervention: transit time Final survey: tolerability, satisfaction, subjective effect (study participants) | — |
Countries
Germany
Contacts
Public ContactKatharina Mansouri
Gittfried Wilhelm Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung
Outcome results
None listed