Multi-strain Probiotic Effects on Self-Reported Constipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDr Anthony Hobson
About this trial
Constipation is a prevalent gastrointestinal condition. Beyond simple lifestyle measures (e.g. increasing fibre intake, hydration, levels of exercise), medical therapies are available for management. However, a sizeable number of sufferers are dissatisfied with drug treatments (either over-the-counter or prescribed), meaning there is an unmet need for alternative therapeutic strategies.
Pre, pro- and synbiotics have emerged as one alternative treatment, and a growing body of evidence now supports their use in a proportion of individuals with mild constipation. However, it is currently not possible to predict which individuals may benefit. A better understanding of an individuals' symptoms and underlying pathophysiology may allow for more targeted treatment.
The multistrain live bacterial food product (probiotic) being tested contains billions of live and active bacteria that has been shown to improve symptoms in the irritable bowel syndrome (IBS: which is 'constipation-predominant' in many). Notably, improvements ('completely resolved' or 'some positive difference') in bowel habit satisfaction, abdominal pain, bloating and urgency, as well as on quality of life have been shown after 4 or more weeks of this probiotc.
This study aims to have 20 participants with self-reported constipation to assess improvements in constipation symptoms, quality of life and measures of gut function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
Participant has Cleveland Clinic constipation score (CCCS) of 9-16 at screening call
Participant is willing to discontinue all other therapies for constipation and undergo washout where applicable.
Participant is a male or non-pregnant female and is 18-70 years of age
Disqualifiers
Women who are pregnant and/or breastfeeding.
Participants who are planning to significantly change their diet (e.g. weight loss program, becoming vegetarian) during the study period.
Participant has had diarrhoea within 7 weeks of screening period.
Prior abdominal surgery involving resection of the small or large bowel.
Trial design
Design model
Single group
Treatments tested in this trial
Multi-strain probiotics
Dietary supplement28-35 days of 70 ml Symprove once daily, to be taken on an empty stomach upon waking. 10 minutes should be taken between ingestion of Symprove before eating and drinking.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Multi-strain Liquid ProbioticExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient Assessment of Constipation-Symptoms (PAC-SYM)
Number of participants with clinically meaningful change in PAC-SYM score (reduction of \>0.6 or \>0.75 points). The PAC-SYM questionnaire is a 12 item validated patient-reported measure of severity of constipation symptoms during the past two weeks.
Time frame
Pre-post comparison (28 days)Secondary outcomes
1
Patient Assessment of Constipation - Quality of Life (PAC-QoL)
Number of participants with clinically meaningful change in PAC-QoL (reduction of \>0.5 or \>1.0 point). A validated questionnaire consisting of 28 items to measure the impact of constipation on a patient's quality of life.
Time frame
Pre-Post comparison (28 days)2
Participant Compliance
Number of participants completing \>75% of breath gas measurements and bowel diary submissions with OMED device. The OMED Health Breath Analyzer is used for breath gas readings at 4 intervals during the day. The bowel diary recorded daily on paper throughout the study capturing movements, symptoms and any medication
Time frame
Pre-Post comparison (28 days)3
Whole Gut Transit Time (ATMO)
Change in whole gut transit time measured by ATMO capsule ATMO capsule is an ingestible electronic medical device measuring gastrointestinal (GI) transit time and environmental conditions as it moves through the digestive tract.
Time frame
Pre-Post comparison (28 days)4
Whole Gut Transit Time (Blue-dye)
Change in whole gut transit time measured by Blue dye transit study baseline period to treatment period. Participants are required to consume a Zoe blue cookie the following morning after both visits 2 and 3. Participants then report when the blue food colour is visible in their stool, checking every time they pass a bowel movement.
Time frame
Pre-Post comparison (28 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr Anthony Hobson
Lead sponsor
The Functional Gut Clinic
Sponsor institution
Source ClinicalTrials.gov