ConstipationNCT04304170
Dietary Supplementation Effects on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit
A study testing VES002 in people with Constipation, run by CEN Biotech at 1 site in France.
Trial summary
This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation evaluate the effects of a supplementation in "symbiotic" on intestinal transit of subjects with few bowel movements per week with a verum group treated with a dietary supplement… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- VES002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2017to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male and female volunteers aged 50-70 years with ≥1 and ≤3 bowel movements per week in the month before the selection visit and in the two weeks before the enrolment visit,
- at least one in four bowel movements had to involve hard faeces or separate lumps of faeces (Bristol scale class 1) in the three months before enrolment.
Who cannot join
- subjects who, in the 30 days before the selection visit or at the time of the visit, had taken drugs, dietary supplements or any foodstuff enhanced in or containing substances, bacteria or yeasts and that might have an effect on the gut and more specifically on intestinal transit, digestive comfort, production of gas, or the occurrence of abdominal pain. Such products were also prohibited throughout the study. The same applied to subjects on a particular diet (vegetarian, vegan, hyper-protein, etc.), a low-calorie diet or under medical treatment which in the investigator's view might interfere with the evaluation of the study criteria (antibiotics, corticoids, anticholinergics, antidepressants, antiemetics, diuretics, calcium channel blockers, antiparkinson drugs, antipsychotics, antacids, analgesics, NSAIDS, H2 receptor antagonists, hypnotics, sedatives, iron supplements, opioids and narcotics, laxatives, anti-diarrhoeal drugs, anti-reflux drugs, etc.),
- subjects who drink more than three glasses of wine a day or two 25 cl glasses of beer a day, or one glass of spirits per day and those who drink more than five cups of coffee per day;
- subjects with a body mass index (BMI) of more than 30,
- subjects with type I or II diabetes,
- subjects with constipation attributable to an organic or anatomical cause;
- subjects with a history of chronic or inflammatory gastro-intestinal disease;
- subjects with a history of digestive tract operation and especially bariatric surgery;
- subjects with a fibre intake exceeding the recommended levels (more than six portions of fruit and vegetables per day according to the PNNS - national nutrition and health programme - questionnaire) or engaging in intense sport for more than 10 hours per week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial of the Effect of Dietary Supplementation With Bifidobacteria and Fructo-oligosaccharides (FOS) on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit
This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation evaluate the effects of a supplementation in "symbiotic" on intestinal transit of subjects with few bowel movements per week with a verum group treated with a dietary supplement composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet and a placebo group treated with a comparative product hat looked strictly identical to the verum and contained only excipients (60% maltodextrin / 40% sucrose).
The claim investigated corresponds to the section of the new EFSA (European Food Safety Authority) guidance of 2016 entitled "Claims on maintenance of normal defecation".
Read the detailed description
Few studies have been made in France of the epidemiology of constipation although it is a frequent reason for visits to the doctor or for seeking advice from pharmacists. The prevalence of constipation in European and North American populations is reportedly of the order of 15% on average and it is 2.2 times more frequent among women than men. Hammond and Harari show there is an increased frequency of constipation from the age of 50 years onwards and that it substantially impacts quality of life. This can be explained in part by significant changes in the workings of the gastro-intestinal system in the course of normal ageing with reduced numbers of bifidobacteria in the gut.
These disorders are a major reason for taking oral and local drugs that are not without their side-effects and entail substantial healthcare costs. lifestyle rules combining appropriate fluid intake, regular physical activity and a high-fibre diet should be systematically recommended to such patients. "Symbiotic" dietary supplements combining probiotics and prebiotics may also be recommended provided that their effects have been properly validated. The symbiotic combination proposed in this clinical study is made up of fructo-oligosaccharides (FOS) sold as Actilight FOS (Beghin Say) and bifidobacteria BB12. Each of these components has been the subject of numerous studies showing improved intestinal transit especially in the elderly. A recent meta-analysis of the main studies published in Medline, Embase and The Cochrane Library has concluded that symbiotic with FOS and probiotics have a positive effect on bowel movement frequency and stool consistency.
The change in European regulations requires that clinical studies be conducted to secure EFSA claims for these dietary supplements. Such studies should also show an objective clinical benefit and factors such as a dose-dependent effect and/or the modification of biological markers that might confirm any such positive effect.
This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation serves this purpose. The claim investigated corresponds to the section of the new EFSA guidance of 2016 entitled "Claims on maintenance of normal defecation".
The primary endpoint of this trial is to evaluate the effect of supplementation in symbiotic on intestinal transit of subjects with few bowel movements per week.
The secondary endpoints are to evaluate:
- both clinical criteria such as changes in stool appearance, quality of life and mood, relief and satisfaction of participants;
- and biological criteria such as changes in markers of gut function, low-grade chronic inflammation markers and gut microbiota markers.
The safety of product use and compliance are also evaluated.
- Conditions
- Constipation
- Being tested
- VES002, Placebo
- Keywords
- Constipation, Probiotic, Prebiotic
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VES002Dietary supplement
The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.
PlaceboOther
The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Verum group | Experimental | The dietary supplement under study was composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet. They came in the form of sachets of powder to be diluted in a glass of water. Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days. Receives: Dietary Supplement: VES002 |
| Placebo group | Placebo comparator | The comparative product was a placebo that looked strictly identical to the verum and contained only excipients (60% maltodextrin / 40% sucrose).They came in the form of sachets of powder to be diluted in a glass of water. Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intestinal transit
Evaluated by the frequency of bowel movements
Measured: Reported daily from Day -14 to Day 30
Secondary outcomes (6)
Changes in stool aspect
Evaluated by the Bristol Stool Form Scale (BSFS) ; The BSFS classifies stools into seven categories, including type 1, separate hard lumps, like nuts; type 2, sausage-shaped, but lumpy; type 3, like a sausage but with cracks on the surface; type 4, like a sausage or snake, smooth and soft; type 5, soft blobs with clear-cut edges; type 6, fluffy pieces with ragged edges, a mushy stool; type 7, watery, no solid pieces [25]. These types are categorized into slow transit (types 1 and 2), normal transit (types 3-5), and fast transit (types 6 and 7).
Measured: Reported daily from Day -14 to Day 30
Changes in quality of life
Evaluated by the quality of life questionnaire SF(Short Form) 12 consisting of 12 questions relating to: physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations and general mental health (psychological distress and psychological well-being). This instrument yields two summary scores: a Mental Component Score from 19 (poor mental condition) to 56 (excellent mental condition) and a Physical Component Score (PCS) from 24 (poor physical condition) to 56 (excellent physical condition).
Measured: Day -14 to Day 30
Mood changes
Evaluated by the Brief Mood Introspection Scale (BMIS) consisting of 16 mood adjectives (Lively, Drowsy, Happy, Grouchy, Sad, Peppy, Tired, Nervous, Caring, Calm, Content, Loving, Gloomy, fed up, Jittery, Active). Subjects were asked to circle the phrases describing their present mood (with XX = definitely do not feel; X = do not feel; V = slightly feel; VV = definitely feel on the diverse adjectives). The BMIS was scored for Pleasant-Unpleasant Mood, Arousal-Calm Mood, Positive-Tired Mood and Negative-Relaxed Mood according to the Mayer's method.
Measured: Reported daily from Day-14 to Day 30
Relief of subjects
Evaluated on the PGI-I (Patient Global Impression of Improvement) scale; The PGI-I is a 1-item questionnaire asking to rate the perceived change in his/her condition in response to therapy from 1 (Very much better) to 7 (Very much worse)
Measured: At Day 30
Satisfaction toward treatment
Evaluated on a 5 points Likert scale (0 : very unsatisfied ; 5 : very satisfied)
Measured: At Day 30
Tolerance: occurrence of diarrhoea
Evaluated especially by the occurrence of diarrhoea
Measured: At Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start21 Feb 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For each subject enrolled in the trial, the planned length of the trial was 44 days composed of a 14 day period at the beginning of the study without taking the trial product and a 30 day period when it was taken. The trial included three visits to the CEN Experimental Centre at D-14, D0 and D30. The product was taken from D1 onwards, the day after the enrolment visit.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vesale Pharmaceutica
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304170
- Sponsor's protocol ID
- C1487
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial of the Effect of Dietary Supplementation With Bifidobacteria and Fructo-oligosaccharides (FOS) on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit
- ClinicalTrials.gov ID
- NCT04304170
- Acronym / sponsor ID
- C1487
- Conditions
- Constipation
- Keywords
- Constipation, Probiotic, Prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Vesale Pharmaceutica
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation evaluate the effects of a supplementation in "symbiotic" on intestinal transit of subjects with few bowel movements per week with a verum group treated with a dietary supplement composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet and a placebo group treated with a comparative product hat looked strictly identical to the verum and contained only excipients (60% maltodextrin / 40% sucrose).
The claim investigated corresponds to the section of the new EFSA (European Food Safety Authority) guidance of 2016 entitled "Claims on maintenance of normal defecation".
Detailed description
Few studies have been made in France of the epidemiology of constipation although it is a frequent reason for visits to the doctor or for seeking advice from pharmacists. The prevalence of constipation in European and North American populations is reportedly of the order of 15% on average and it is 2.2 times more frequent among women than men. Hammond and Harari show there is an increased frequency of constipation from the age of 50 years onwards and that it substantially impacts quality of life. This can be explained in part by significant changes in the workings of the gastro-intestinal system in the course of normal ageing with reduced numbers of bifidobacteria in the gut.
These disorders are a major reason for taking oral and local drugs that are not without their side-effects and entail substantial healthcare costs. lifestyle rules combining appropriate fluid intake, regular physical activity and a high-fibre diet should be systematically recommended to such patients. "Symbiotic" dietary supplements combining probiotics and prebiotics may also be recommended provided that their effects have been properly validated. The symbiotic combination proposed in this clinical study is made up of fructo-oligosaccharides (FOS) sold as Actilight FOS (Beghin Say) and bifidobacteria BB12. Each of these components has been the subject of numerous studies showing improved intestinal transit especially in the elderly. A recent meta-analysis of the main studies published in Medline, Embase and The Cochrane Library has concluded that symbiotic with FOS and probiotics have a positive effect on bowel movement frequency and stool consistency.
The change in European regulations requires that clinical studies be conducted to secure EFSA claims for these dietary supplements. Such studies should also show an objective clinical benefit and factors such as a dose-dependent effect and/or the modification of biological markers that might confirm any such positive effect.
This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation serves this purpose. The claim investigated corresponds to the section of the new EFSA guidance of 2016 entitled "Claims on maintenance of normal defecation".
The primary endpoint of this trial is to evaluate the effect of supplementation in symbiotic on intestinal transit of subjects with few bowel movements per week.
The secondary endpoints are to evaluate:
- both clinical criteria such as changes in stool appearance, quality of life and mood, relief and satisfaction of participants;
- and biological criteria such as changes in markers of gut function, low-grade chronic inflammation markers and gut microbiota markers.
The safety of product use and compliance are also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- For each subject enrolled in the trial, the planned length of the trial was 44 days composed of a 14 day period at the beginning of the study without taking the trial product and a 30 day period when it was taken. The trial included three visits to the CEN Experimental Centre at D-14, D0 and D30. The product was taken from D1 onwards, the day after the enrolment visit.
| Arm | Type | Receives |
|---|---|---|
| Verum group | Experimental | Dietary Supplement: VES002The dietary supplement under study was composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet. They came in the form of sachets of powder to be diluted in a glass of water. Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days. |
| Placebo group | Placebo comparator | Other: PlaceboThe comparative product was a placebo that looked strictly identical to the verum and contained only excipients (60% maltodextrin / 40% sucrose).They came in the form of sachets of powder to be diluted in a glass of water. Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy male and female volunteers aged 50-70 years with ≥1 and ≤3 bowel movements per week in the month before the selection visit and in the two weeks before the enrolment visit,
- at least one in four bowel movements had to involve hard faeces or separate lumps of faeces (Bristol scale class 1) in the three months before enrolment.
Key exclusion criteria (8 listed)
- subjects who, in the 30 days before the selection visit or at the time of the visit, had taken drugs, dietary supplements or any foodstuff enhanced in or containing substances, bacteria or yeasts and that might have an effect on the gut and more specifically on intestinal transit, digestive comfort, production of gas, or the occurrence of abdominal pain. Such products were also prohibited throughout the study. The same applied to subjects on a particular diet (vegetarian, vegan, hyper-protein, etc.), a low-calorie diet or under medical treatment which in the investigator's view might interfere with the evaluation of the study criteria (antibiotics, corticoids, anticholinergics, antidepressants, antiemetics, diuretics, calcium channel blockers, antiparkinson drugs, antipsychotics, antacids, analgesics, NSAIDS, H2 receptor antagonists, hypnotics, sedatives, iron supplements, opioids and narcotics, laxatives, anti-diarrhoeal drugs, anti-reflux drugs, etc.),
- subjects who drink more than three glasses of wine a day or two 25 cl glasses of beer a day, or one glass of spirits per day and those who drink more than five cups of coffee per day;
- subjects with a body mass index (BMI) of more than 30,
- subjects with type I or II diabetes,
- subjects with constipation attributable to an organic or anatomical cause;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VES002The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast. | Dietary supplement | Verum group |
| PlaceboThe sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast. | Other | Placebo group |
Primary outcome
Changes in intestinal transit
Time frame: Reported daily from Day -14 to Day 30
Evaluated by the frequency of bowel movements
6 secondary outcomes
Changes in stool aspect
Time frame: Reported daily from Day -14 to Day 30
Changes in quality of life
Time frame: Day -14 to Day 30
Mood changes
Time frame: Reported daily from Day-14 to Day 30
Relief of subjects
Time frame: At Day 30
Satisfaction toward treatment
Time frame: At Day 30
Tolerance: occurrence of diarrhoea
Time frame: At Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VES002 in people with Constipation, run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in intestinal transit (time frame: Reported daily from Day -14 to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.