A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constipation

NCT02073006 | Completed Phase 2

• 1 other identifier: AFCRO-048
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Constipation is common in the general population, especially in women and in the elderly. Hard stool is a complaint often associated with constipation, which suggests that stool softening would provide a major benefit in the strategy of treatment. This investigative fibre product is primarily a soluble dietary fibre with added probiotics and a prebiotic. It is not digested in the small intestine and partly remains undigested by bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora, reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the improvement of intestinal motility. The objective of this study is to assess if this investigative, fibre product effects the number of bowel movements per week and if this in turn impacts quality of life and symptoms of constipation.

Conditions

Constipation

Keywords

Chronic; Functional; Constipation; less than 3 bowel movements per week

Outcome Measures

Primary Outcomes (1)

• Number of bowel movements per week

  4 weeks

Secondary Outcomes (4)

• Stool consistency, as measured by the Bristol Stool Form Scale

  4 weeks

• Quality of life as measured by the Quality of Life Questionnaire (PAC-QOL)

  4 weeks

• Constipation symptoms as measured by PAC-SYM

  4 weeks

• Laxative use by subjects with functional constipation

  4 weeks

Study Arms (2)

Natural Fibre Supplement

ACTIVE COMPARATOR

2 doses per day for 4 weeks

Dietary Supplement: Natural Fibre Supplement

Placebo

PLACEBO COMPARATOR

2 doses per day for 4 weeks

Dietary Supplement: Natural Fibre Supplement

Interventions

Natural Fibre Supplement DIETARY_SUPPLEMENT

Natural Fibre Supplement 2 doses per day for 4 weeks

Also known as: Lepicol

Natural Fibre Supplement; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be considered eligible for enrolment into the study, subjects must;
• Be able to give written informed consent,
• Be between 18 and 80 years of age,
• Subject has chronic functional constipation according to the Rome III Diagnostic Criteria, where (f) is mandatory.
• i. Must include two or more of the following:
• Straining during at least 25% of defæcations
• Lumpy or hard stools in at least 25% of defæcations
• Sensation of incomplete evacuation for at least 25% of defæcations
• Sensation of anorectal obstruction / blockage for at least 25% of defaecations
• Manual manœuvers to facilitate at least 25% of defæcations (e.g., digital evacuation, support of the pelvic floor)
• Fewer than 3 defæcations per week ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome \* Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis
• Subjects will continue on his/her normal diet,
• The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study.

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the below criteria;
• Are less than 18 and greater than 80 years of age,
• Females are pregnant, lactating or wish to become pregnant during the study.
• Are hypersensitive to any of the components of the test product,
• Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
• Subject has an obstructive or metabolic aetiology for constipation,
• Subject has a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
• Subject has used a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit,
• Subject has a history of drug and/or alcohol abuse at the time of enrolment
• Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
• Subjects may not be receiving treatment involving experimental drugs,
• If the subject has been in a recent experimental trial, these must have been completed not less than 90 days prior to this study.
• Have a malignant disease or any concomitant end-stage organ disease

Sponsors & Collaborators

• Atlantia Food Clinical Trials: lead

Study Sites (1)

Atlantia Food Clinical Trials, University College Cork

Cork, Ireland

Location

MeSH Terms

Conditions

Constipation; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Fergus Shanahan, MD,FRCP,FACG

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

IE (1)