Probiotics and Gut Health

NCT01874301 | Completed

• 1 other identifier: 12.05.NRC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal discomfort regularly affects \>25% of the population worldwide. One of the major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of \~15%, and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel. Previous studies have shown that probiotics improve colonic transit times in constipated patients. In addition, several other studies, employing a range of different probiotic strains, have shown a significant increase in defaecation frequency and improvement in stool consistency. However, the clinical relevance of these results is uncertain, due to small sample sizes and limitations in study methodology. The current study is designed to compare changes in gut transit time and gastrointestinal symptoms following 4 weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled manner, in adults with constipation.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Whole gut transit time- 2 groups

  To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing probiotics in high quantity, compared to those consuming placebo

  After 2 weeks consumption of the study product

Secondary Outcomes (11)

• Regional colonic transit time- all groups

  After 2 weeks consumption of the study product

• Whole gut and Regional colonic transit time- all groups

  After 4 weeks consumption of the study product

• Whole gut transit time- all groups

  After 2 weeks consumption of the study product

• Response to the Patient assessment of constipation symptoms (PAC-SYM) - all groups

  After 2&4 weeks consumption of the study product

• Cleveland Clinic constipation score - all groups

  After 1&2&4 weeks consumption of the study product

Other Outcomes (3)

• Correlation between lifestyle, diet and blood/stool biomarkers with gut function and symptoms- all groups

  After 2&4 weeks consumption of the study product

• Long-term changes in gut function and gastrointestinal symptoms

  After 4 weeks follow-up (week 8)

• Adverse Events

  Through the study product consumption period (4 weeks)

Study Arms (3)

High quantity probiotic food product

EXPERIMENTAL

Other: High quantity probiotic

Low quantity probiotic food product

EXPERIMENTAL

Other: Low quantity probiotic

Placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

High quantity probiotic OTHER

The intervention type is food product

High quantity probiotic food product

Low quantity probiotic OTHER

The intervention type is food product

Low quantity probiotic food product

placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 - 65
• 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):a). average Bristol stool type of 1 - 4 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week b). plus at least ONE of: 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 8-15
• Willing and able to consume a milk-based product daily for 4 weeks
• Low-moderate fibre intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fibre Screener
• No 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. Also, willing to discontinue fibre supplementation and other probiotics, prebiotics, fermented milk, yoghurt or laxatives at least 2 weeks prior to and during the consumption phase and the follow-up phase
• Ability to understand the patient information sheet and instructions in English, and able to provide informed consent

You may not qualify if:

• Subjects who report lactose intolerance and/or are allergic to cow milk protein or soya
• Regular consumption of probiotics, fibre supplements (including prebiotics), fermented milk, yogurt, laxatives, or those unwilling to discontinue these at least 2 weeks prior to and during the study
• Pregnant or breast-feeding women
• Ongoing other diagnosed gastrointestinal disease or complication (e.g. IBS, Crohn's disease, Coeliac disease, chronic diarrhoea, etc.)
• 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
• Ongoing therapy with drugs known to affect gut motility, such as prokinetic agents (such as metoclopramide, domperidone, erythromycin, azithromycin), anti-emetic agents, anxiolytics (such as benzodiazepines), antidepressive agents (such as trycyclics, SSRI's etc.), narcotic analgesic agents (such as methadone, fentanyl), anticholinergic agents for IBS, medications for constipation (including enemas, cathartics, polyethylene glycol solutions), 5HT3 antagonists, anti-diarrheal agents (such as loperamide), opiate agents used to treat diarrhoea, NSAIDs (more than once daily), other antibiotics taken during or within 4 weeks of study onset, magnesium-containing antacids
• 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)
• HADS score of \>11
• Ongoing alcohol, drug, or medication abuse
• Self-reported symptoms of pelvic organ prolapse
• Moderate or severe active local anorectal problems such as recurrent anal fissures, bleeding, large prolapsing haemorrhoids, etc
• Participation in another study with any investigational product within 3 months of screening

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Wingate Institute, Queen Mary University of London

London, E1 2AJ, United Kingdom

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Scott, PhD

  Wingate Institute, Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: May 31, 2013
• First Posted: June 11, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

GB (1)