Evaluation of changes in gut transit time and gastrointestinal symptoms following the consumption of a fiber containing product in adults with constipation.

Completed

Conditions: Constipation
Stoppage
10017977

Registration Number: NL-OMON40696

Lead Sponsor: estec

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

• Adult men or women (female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period)
• Age 18 - 75
• BMI: 18.5 - 29.9 kg/m2
• Symptoms of constipation for a minimum of 3 months
• Recruitment based on simplified core ROME III diagnostic criteria for functional constipation (based on specific screening questions):
o average Bristol stool type of 1 - 3 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week
o plus at least ONE of the following at screening:
* straining on at least 25% of defaecations
* sensation of incomplete evacuation on at least 25% of defaecations
* sensation of anorectal obstruction / blockage on at least 25% of defaecations
* use of manual manoeuvres on at least 25% of defaecations.
• Cleveland Clinic constipation score (CCCS) of 8-20
• Low-moderate fibre intake (<=18g) determined by the semi-quantitative food intake screener known as the Block Fibre Screener
• Ability to understand the patient information sheet and instructions in Dutch, and able to provide informed consent

Exclusion Criteria

• Subjects who report lactose intolerance and/or are allergic to soy or cow milk protein
• Pregnant or breast-feeding women
• Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Coeliac disease, chronic diarrhoea)
• Any clinical relevant abnormalities in the screening visit medical examination or alarm features such as sudden unintentional weight loss, rectal bleeding, recent change in bowel habit (<3 months), abdominal pain and stool positive for occult blood
• Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendicectomy
• Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease
• Chronic medication that in opinion of the investigator would impact gut motility
• Illness that may preclude the subject's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in >2 weeks inability to work in the 3 months before the study start
• Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility)
• Ongoing alcohol, drug, or medication abuse (anamnesis only)
• Self-reported symptoms of pelvic organ prolapse
• Moderate or severe active local anorectal problems such as recurrent anal fissures, bleeding, large prolapsing haemorrhoids, etc
• Regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit and no more than 6 standard doses in the past 1 month prior to the screening visit
• Participation in another study with any investigational product within 3 months of screening
• Investigator believes that the participant is physically or mentally unfit to participate in the trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate change in whole gut transit time at the mid-consumption period<br /><br>timepoint (+2 weeks) in constipated patients consuming the study food product<br /><br>containing fiber in high quantity (Group 1), compared to those consuming<br /><br>placebo (Group 3). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Assess change in gastrointestinal symptoms during the consumption period of<br /><br>the study food product<br /><br>• Assess tolerance to the study food product<br /><br>• Evaluate physiological and symptomatic endpoint(s) that best correlate with<br /><br>gut transit time<br /><br>• Evaluate changes in regional (right colon, left colon, and rectosigmoid)<br /><br>colonic transit times at the mid-consumption period timepoint (+2 weeks)<br /><br>• Evaluate change in whole gut transit time at the mid-consumption period<br /><br>timepoint (+2 weeks) in constipated patients consuming the study food product<br /><br>containing fiber in low quantity (Group 2), compared to those consuming placebo<br /><br>(Group 3)</p><br>