Prebiotics EffectPIBNCT02287844
Prebiotics Change Microflora and Decrease LPS
A study testing XOS and INU-XOS in people with Prebiotics Effect, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prebiotics Effect
- What is being tested?
- XOS and INU-XOS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Dec 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable weight (+/- 3 kg) for the last 3 months
- Body Mass Index (BMI) between 18.5 and 27 kg/m²
- Consuming between 13 and 18 g of dietary fiber a day
- Student on campus at the Institut Polytechnique LaSalle Beauvais
- Informed consent form signed
- Able to follow the requirement of the study
- Have a social security
Who cannot join
- Has a serious pathology
- Has a gastrointestinal, vesicular or pancreatic disease
- Took an antibiotic or a laxative treatment in the last 6 months
- Surgery of the gastrointestinal tract in the last 12 months
- Orange juice intolerance
- Chronic or recurring diarrhea, constipation or abdominal pain
Show all 13Show fewer
- Taking drugs known to have an effect on the gastrointestinal, pancreatic and vesicular function
- Recent gastroenteritis or foodborne illness
- Diabetes
- Consuming regularly of probiotics- or prebiotics-enriched products in the last month
- Drinking more than 3 glasses of alcohol a day
- Is deprived of liberty
- Is under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xylo-oligosaccharide (XOS) in Combination With Inulin Modulates Both the Intestinal Environment and Immune Status in Healthy Subjects, While XOS Alone Only Shows Prebiotic Properties
The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.
Read the detailed description
The study followed a randomized, parallel placebo-controlled double-blind design.
A semi-quantitative dietary survey was performed at enrollment in order to assess the usual dietary fiber intake in order to select the target population consuming 13 to 18 g/day. The volunteers were instructed to follow dietary guidelines to maintain their fiber intake during a two-week stabilization phase and then throughout the intervention.
As all volunteers were living on-site and taking all meals at the Institut Polytechnique LaSalle Beauvais cafeteria, the content of each meal could be closely controlled during the week. A 3-day dietary survey was performed at the end of the stabilization period and repeated at the end of the intervention in order to assess the stability of the diet.
The 60 volunteers were randomly assigned to one of three groups and received daily the intervention for 4 weeks.
- Conditions
- Prebiotics Effect
- Being tested
- XOS, INU-XOS, Placebo
- Keywords
- Xylo-oligosaccharides, Immunonutrition, Prebiotics, Lipopolysaccharides, Cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XOSOther
5 g of XOS everyday for 4 weeks.
INU-XOSOther
1 g of XOS and 3 g of inulin everyday for 4 weeks.
PlaceboOther
6.64 g of maltodextrins everyday for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| XOS group | Experimental | Subjects consumed 6.64 g of a XOS-enriched compound derived from wheat arabinoxylans (5 g of XOS) everyday for 4 weeks. Receives: Other: XOS |
| INU-XOS group | Experimental | Subjects consumed 6.64 g of a mixture containing inulin-type fructans, XOS and maltodextrins (3 g of inulin and 1 g of XOS) everyday for 4 weeks. Receives: Other: INU-XOS |
| Placebo | Active comparator | Subjects consumed 6.64 g of wheat maltodextrins everyday for 4 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the intestinal bifidobacterium at 4 weeks.
Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).
Measured: 4 weeks
Secondary outcomes (32)
Change from Baseline in the intestinal bifidobacterium at 2 weeks.
Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).
Measured: 2 weeks
Change from 2 weeks in the intestinal bifidobacterium at 4 weeks.
Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).
Measured: Between 2 and 4 weeks
Change from Baseline in total microbiota and composition in the feces at 4 weeks.
Total bacterial count and specific bacterial profile analyzed by quantitative PCR.
Measured: 4 weeks
Change from Baseline in total microbiota and composition in the feces at 2 weeks.
Total bacterial count and specific bacterial profile analyzed by quantitative PCR.
Measured: 2 weeks
Change from 2 weeks in total microbiota and composition in the feces at 4 weeks.
Total bacterial count and specific bacterial profile analyzed by quantitative PCR.
Measured: Between 2 and 4 weeks
Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks
Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.
Measured: 4 weeks
Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 2 weeks
Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.
Measured: 2 weeks
Change from 2 weeks of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks
Acetic acid (C2), propionic acid (C3) and butyric acid (C4) extracted and measured.
Measured: Between 2 and 4 weeks
Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.
Measured: 4 weeks
Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 2 weeks.
Measured: 2 weeks
Change from 2 weeks in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.
Measured: Between 2 and 4 weeks
Change from Baseline in the phenol and p-Cresol in the feces at 4 weeks.
Measured: 4 weeks
Change from Baseline in the phenol and p-Cresol in the feces at 2 weeks.
Measured: 2 weeks
Change from 2 weeks in the phenol and p-Cresol in the feces at 4 weeks.
Measured: Between 2 and 4 weeks
Change from Baseline in the faecal pH and dry matter at 4 weeks.
Measured: 4 weeks
Change from Baseline in the faecal pH and dry matter at 2 weeks.
Measured: 2 weeks
Change from 2 weeks in the faecal pH and dry matter at 4 weeks.
Measured: Between 2 and 4 weeks
Change from Baseline in secretory Immunoglobulin A (IgA) at 4 weeks.
Measured with s-IgA ELISA kit.
Measured: 4 weeks
Change from Baseline in secretory Immunoglobulin A (IgA) at 2 weeks.
Measured with s-IgA ELISA kit.
Measured: 2 weeks
Change from 2 weeks in secretory Immunoglobulin A (IgA) at 4 weeks.
Measured with s-IgA ELISA kit.
Measured: Between 2 and 4 weeks
Change from Baseline in cytokines at 4 weeks
Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10
Measured: 4 weeks
Change from Baseline in cytokines at 2 weeks
Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10
Measured: 2 weeks
Change from 2 weeks in cytokines at 4 weeks
Tumor Necrosis Factor (TNF)-alpha and Interleukine(IL)-10
Measured: Between 2 and 4 weeks
Change from Baseline in dietary intakes at 4 weeks
Data extracted from a 3-day food diary.
Measured: 4 weeks
Change from Baseline in dietary intakes at 2 weeks
Data extracted from a 3-day food diary.
Measured: 2 weeks
Change from 2 weeks in dietary intakes at 4 weeks
Data extracted from a 3-day food diary.
Measured: Between 2 and 4 weeks
Change from Baseline of circulating lipopolysaccharides (LPS) at 4 weeks.
Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.
Measured: 4 weeks
Change from Baseline of circulating lipopolysaccharides (LPS) at 2 weeks.
Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.
Measured: 2 weeks
Change from 2 weeks of circulating lipopolysaccharides (LPS) at 4 weeks.
Measured in plasma sample using the limulus amebocyle lysate chromogenic endpoint assay.
Measured: Between 2 and 4 weeks
Change from Baseline in the subjects' tolerance to the test products at 4 weeks.
Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm).Stool frequency (stool per day).
Measured: 4 weeks
Change from Baseline in the subjects' tolerance to the test products at 2 weeks.
Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm). Stool frequency (stool per day).
Measured: 2 weeks
Change from 2 weeks in the subjects' tolerance to the test products at 4 weeks.
Flatulence, bloating, rumbling, cramps, nausea, stool consistency on a Visual Analog Scale (10 cm). Stool frequency (stool per day).
Measured: Between 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prebiotics EffectStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Polytechnique LaSalle Beauvais
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287844
- Sponsor's protocol ID
- 2007-A00273-50
- Acronym
- PIB
- Status last verified
- Nov 2014
- First submitted
- 4 Nov 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xylo-oligosaccharide (XOS) in Combination With Inulin Modulates Both the Intestinal Environment and Immune Status in Healthy Subjects, While XOS Alone Only Shows Prebiotic Properties
- ClinicalTrials.gov ID
- NCT02287844
- Acronym / sponsor ID
- PIB / 2007-A00273-50
- Conditions
- Prebiotics Effect
- Keywords
- Xylo-oligosaccharides, Immunonutrition, Prebiotics, Lipopolysaccharides, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Collaborators
- Institut Polytechnique LaSalle Beauvais
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Nov 2014 (estimated)
- 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.
The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharides (XOS) and of an inulin-and-XOS mixture (INU-XOS) and to determine their effect on endotoxaemia (lipopolysaccharides (LPS)) and immune parameters. In this randomized, parallel, placebo-controlled, double-blind study, sixty healthy volunteers were randomly assigned to three groups, receiving either 5 g XOS, INU-XOS (3 g inulin +1 g XOS) or an equivalent weight of wheat maltodextrins (placebo) during 4 weeks.
Detailed description
The study followed a randomized, parallel placebo-controlled double-blind design.
A semi-quantitative dietary survey was performed at enrollment in order to assess the usual dietary fiber intake in order to select the target population consuming 13 to 18 g/day. The volunteers were instructed to follow dietary guidelines to maintain their fiber intake during a two-week stabilization phase and then throughout the intervention.
As all volunteers were living on-site and taking all meals at the Institut Polytechnique LaSalle Beauvais cafeteria, the content of each meal could be closely controlled during the week. A 3-day dietary survey was performed at the end of the stabilization period and repeated at the end of the intervention in order to assess the stability of the diet.
The 60 volunteers were randomly assigned to one of three groups and received daily the intervention for 4 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XOS group | Experimental | Other: XOSSubjects consumed 6.64 g of a XOS-enriched compound derived from wheat arabinoxylans (5 g of XOS) everyday for 4 weeks. |
| INU-XOS group | Experimental | Other: INU-XOSSubjects consumed 6.64 g of a mixture containing inulin-type fructans, XOS and maltodextrins (3 g of inulin and 1 g of XOS) everyday for 4 weeks. |
| Placebo | Active comparator | Other: PlaceboSubjects consumed 6.64 g of wheat maltodextrins everyday for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stable weight (+/- 3 kg) for the last 3 months
- Body Mass Index (BMI) between 18.5 and 27 kg/m²
- Consuming between 13 and 18 g of dietary fiber a day
- Student on campus at the Institut Polytechnique LaSalle Beauvais
- Informed consent form signed
Key exclusion criteria (13 listed)
- Has a serious pathology
- Has a gastrointestinal, vesicular or pancreatic disease
- Took an antibiotic or a laxative treatment in the last 6 months
- Surgery of the gastrointestinal tract in the last 12 months
- Orange juice intolerance
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 |
|---|---|---|
| XOS5 g of XOS everyday for 4 weeks. | Other | XOS group |
| INU-XOS1 g of XOS and 3 g of inulin everyday for 4 weeks. | Other | INU-XOS group |
| Placebo6.64 g of maltodextrins everyday for 4 weeks. | Other | Placebo |
Primary outcome
Change from Baseline in the intestinal bifidobacterium at 4 weeks.
Time frame: 4 weeks
Dosage by count in the feces by Reverse transcription polymerase chain reaction (RT-PCR).
32 secondary outcomes
Change from Baseline in the intestinal bifidobacterium at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in the intestinal bifidobacterium at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in total microbiota and composition in the feces at 4 weeks.
Time frame: 4 weeks
Change from Baseline in total microbiota and composition in the feces at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in total microbiota and composition in the feces at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks
Time frame: 4 weeks
Change from Baseline of short-chain fatty acids (C2, C3, C4) in the feces at 2 weeks
Time frame: 2 weeks
Change from 2 weeks of short-chain fatty acids (C2, C3, C4) in the feces at 4 weeks
Time frame: Between 2 and 4 weeks
Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.
Time frame: 4 weeks
Change from Baseline in the alpha-glucosidase and beta-glucuronidase activities in the feces at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in the alpha-glucosidase and beta-glucuronidase activities in the feces at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in the phenol and p-Cresol in the feces at 4 weeks.
Time frame: 4 weeks
Change from Baseline in the phenol and p-Cresol in the feces at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in the phenol and p-Cresol in the feces at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in the faecal pH and dry matter at 4 weeks.
Time frame: 4 weeks
Change from Baseline in the faecal pH and dry matter at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in the faecal pH and dry matter at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in secretory Immunoglobulin A (IgA) at 4 weeks.
Time frame: 4 weeks
Change from Baseline in secretory Immunoglobulin A (IgA) at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in secretory Immunoglobulin A (IgA) at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in cytokines at 4 weeks
Time frame: 4 weeks
Change from Baseline in cytokines at 2 weeks
Time frame: 2 weeks
Change from 2 weeks in cytokines at 4 weeks
Time frame: Between 2 and 4 weeks
Change from Baseline in dietary intakes at 4 weeks
Time frame: 4 weeks
Change from Baseline in dietary intakes at 2 weeks
Time frame: 2 weeks
Change from 2 weeks in dietary intakes at 4 weeks
Time frame: Between 2 and 4 weeks
Change from Baseline of circulating lipopolysaccharides (LPS) at 4 weeks.
Time frame: 4 weeks
Change from Baseline of circulating lipopolysaccharides (LPS) at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks of circulating lipopolysaccharides (LPS) at 4 weeks.
Time frame: Between 2 and 4 weeks
Change from Baseline in the subjects' tolerance to the test products at 4 weeks.
Time frame: 4 weeks
Change from Baseline in the subjects' tolerance to the test products at 2 weeks.
Time frame: 2 weeks
Change from 2 weeks in the subjects' tolerance to the test products at 4 weeks.
Time frame: Between 2 and 4 weeks
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 17 Nov 2014.
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 XOS and INU-XOS in people with Prebiotics Effect, run by Institut Pasteur de Lille 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 7 inclusion and 13 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 17 Nov 2014. 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. 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?
Change from Baseline in the intestinal bifidobacterium at 4 weeks. (time frame: 4 weeks). 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 17 Nov 2014; AzTrials last refreshed its copy on 28 Oct 2026.