Dietary Supplementation Effects on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit

NCT04304170 | Completed

• 1 other identifier: C1487
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 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".

Conditions

Constipation

Keywords

Constipation; Probiotic; Prebiotic

Outcome Measures

Primary Outcomes (1)

• Changes in intestinal transit

  Evaluated by the frequency of bowel movements

  Reported daily from Day -14 to Day 30

Secondary Outcomes (6)

• Changes in stool aspect

  Reported daily from Day -14 to Day 30

• Changes in quality of life

  Day -14 to Day 30

• Mood changes

  Reported daily from Day-14 to Day 30

• Relief of subjects

  At Day 30

• Satisfaction toward treatment

  At Day 30

Other Outcomes (4)

• Plasma peptides

  At Day -7 and Day 30

• Gut microbiota analyses

  At Day -7 and Day 30

• Low-grade inflammation plasma markers

  At Day -7 and Day 30

Study Arms (2)

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.

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.

Other: Placebo

Interventions

VES002 DIETARY_SUPPLEMENT

The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.

Verum group

Placebo OTHER

The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.

Placebo group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CEN Biotech: lead
• Vesale Pharmaceutica: collaborator

Study Sites (1)

CEN Nutriment

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

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

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 11, 2020
• Study Start: February 21, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)