Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria in Middle-aged Adults

NCT04283266 | Completed DMC

• 1 other identifier: VesalePharma
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the impact of a synbiotic containing fructo-oligosaccharides (FOS) and Bifidobacteria (VES002 LMG P-28149) on intestinal transit in middle-aged subjects characterized by a low number of defecations per week.

Conditions

Constipation

Keywords

probiotics; constipation; FOS

Outcome Measures

Primary Outcomes (1)

• intestinal transit

  stool frequency and consistency were investigated through daily self-assessment using the Bristol Stool Form Scale (BSFS). The BSFS classifies stools into 7 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

  daily evaluation (day-14 to day 30)

Secondary Outcomes (7)

• stool consistency

  daily evaluation (day-14 to day 30)

• evaluation of quality of life

  day 0 and day 30

• mood

  daily evaluation (day-14 to day 30)

• abdominal pain and intestinal discomfort

  day -14 and day 30

• plasma inflammatory markers (pg/ml)

  day 0 and day 30

Study Arms (2)

Synbiotic group

ACTIVE COMPARATOR

The synbiotic was composed of fructo-oligosaccharides (FOS): 4.95 g/ sachet and Bifidobacterium animalis lactis: 5 billion / sachet (n=13)

Dietary Supplement: Synbiotic

Placebo group

PLACEBO COMPARATOR

A placebo was composed of maltodextrin (60%) and sucrose (40%) : 5 g /sachet (n =14)

Dietary Supplement: Placebo

Interventions

Synbiotic DIETARY_SUPPLEMENT

Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of synbiotic (Bifidobaterium animalis lactis Vesalius 002 and Fructo-Oligosaccharrides) for 5 days, then they received daily 1 sachet for the next 25 days

Synbiotic group

Placebo DIETARY_SUPPLEMENT

Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of placebo (maltodextrin and sucrose) for 5 days, then they received daily 1 sachet for the next 25 days

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:

• Free and informed consent
• Healthy male and female aged 50-70 years
• Patient 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 that might have an effect on primary and secondary outcomes.
• Such products were also prohibited throughout the study.
• Subjects on a particular diet or who were under medical treatment that in the investigator's viewpoint might interfere with the evaluation of the study criteria
• 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.
• Subjects 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 including bariatric surgery;

Sponsors & Collaborators

• Vesale Pharmaceutica: lead
• Université Catholique de Louvain: collaborator
• University of Liege: collaborator

MeSH Terms

Conditions

Constipation

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

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: November 12, 2019
• First Posted: February 25, 2020
• Study Start: June 12, 2016
• Primary Completion: October 29, 2018
• Study Completion: January 31, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share