Probiotics - Clinical trial details 

Recruitment status:

Not recruiting

Primary Sponsor:

Nestlé

Recruitment countries:

United Kingdom

Health condition studied:

Constipation

URL:

Link to the clinical trial website

About the trial

Interventions:

Other: High quantity probiotic
Other: Low quantity probiotic
Other: placebo

Key inclusion and exclusion criteria:

• 
  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 - 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
  
  Exclusion Criteria:
  
  - 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
  
  - Investigator believes that the participant may be uncooperative and/or noncompliant
  and should therefore not participate in the study
  

• Age minimum:  18 Years
• Age maximum:  65 Years
• Gender:  Both

Primary outcomes:

Whole gut transit time- 2 groups

Secondary outcomes:

Cleveland Clinic constipation score - all groups
Ease of passage - all groups
Global Constipation Symptom Score - all groups
Regional colonic transit time- all groups
Response to the constipation quality of life (PAC-QOL)questionnaires - all groups
Response to the Patient assessment of constipation symptoms (PAC-SYM) - all groups
Stool consistency - all groups
Stool frequency- all groups
Tolerance to the study product- all groups
Whole gut and Regional colonic transit time- all groups
Whole gut transit time- all groups

Target sample size:

120

Study type:

Interventional

Study design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Contacts:

• Name:   Mark Scott, PhD
• Address: 
• Phone: 
• Email: 
• Affiliation:  Wingate Institute, Queen Mary University of London

Technical details

Scientific title:

Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Probiotic Food Product in Adults With Constipation

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT01874301

Secondary ID:

12.05.NRC

Register:

ClinicalTrials.gov

Date of registration:

31/05/2013

Date of first enrollment:

November 2013

Last refreshed:

23 November 2015