Improving Constipation by Stimulating Fiber Intake Using Personalized

Status Completed

Clinical Trial Summary

Rationale: constipation-related complaints are prevalent in 5-20% of the population. Dietary fibers play a crucial role in improving and maintaining gut health, increasing stool weight, stool frequency and improvement of stool consistency. Currently, very few adults meet the recommendation of 30 (females) or 40 (males) grams of fiber per day. Personalized dietary advice may be the solution to increase dietary fiber intake and reduce constipation-related complaints in large populations. Objective: To investigate the effectiveness of personalized dietary advice (PDA) in reducing constipation-related complaints, by increasing dietary fiber intake in people with constipation-related complaints. Study design: This study has a one-group pre-test post-test design with a run-in period. The duration of the study is 8 weeks, which includes a 4-week run-in phase and a 4-week intervention period. All subjects receive the PDA. Study population: adult subjects with constipation-related complaints, defined as predominant Bristol stool form between 1-4 and not satisfied with their bowel habits (scale ranging from 1-10, cut-off <6). Possibly stool frequency ≤4 stools per week will be included as a definition. Subjects need to have a relatively low dietary fiber intake defined as <26 grams (females) or <33 grams (males), which is ≥15% below the recommendation of fiber intake. Intervention: personalized advice based on their habitual food pattern (as assessed using a food frequency questionnaire) and preferences. Based on a special algorithm, the PDA provides high fiber alternatives for low-fiber products that subjects currently use, close to their current eating behavior, to help increase dietary fiber intake. This PDA will be provided using an online web-portal. Main study parameters/endpoints:primary outcomes are stool pattern, gastrointestinal complaints and constipation quality of life and severity. Secondary parameters include dietary fiber intake, physical activity, body weight, psychological questionnaires, and fecal microbiota composition and metabolite levels. Furthermore, the PDA will be evaluated.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Constipation

Clinical Trial Details

NCT number	NCT04457791
Study type	Interventional
Source	Wageningen University
Contact
Status	Completed
Phase	N/A
Start date	August 31, 2020
Completion date	November 2, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Recruiting	`NCT06292949` - Clinical Study of Resistant Starch in Improving Constipation	N/A
Recruiting	`NCT04132661` - MRI Assessment of Mode of Action of Bisacodyl, Single Dose	Phase 4
Terminated	`NCT02839889` - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)	Phase 4
Completed	`NCT02726295` - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study	Phase 4
Recruiting	`NCT02255747` - Anal Dilatation for Infants and Children With Constipation	N/A
Completed	`NCT02246647` - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed	`NCT01566409` - Maintenance Treatment for Children With Constipation	N/A
Completed	`NCT02863848` - Effect of Inulin-type Fructans on Constipated Children.	N/A
Completed	`NCT01695915` - Diurnal Variation in Rectal Diameter	N/A
Completed	`NCT02658201` - Ultrafast MRI Imaging to Exclude Constipation	N/A
Completed	`NCT01710579` - Normal Values in Ano-rectal 3D High Resolution Manometry	N/A
Completed	`NCT01474499` - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation	Phase 3
Completed	`NCT01438567` - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy	Phase 3
Completed	`NCT01411501` - Efficacy and Safety of Acupuncture for Functional Constipation	Phase 3
Completed	`NCT01170039` - The Effectiveness of Lubiprostone in Constipated Diabetics	Phase 4
Completed	`NCT00931853` - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).	Phase 3
Active, not recruiting	`NCT02442115` - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Completed	`NCT00994851` - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.	Phase 3
Terminated	`NCT01003249` - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice — PAC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms