PrebioticsNCT03336385
Prebiotic Supplementation and Intestinal Barrier Function in Elderly: a RCT
A study testing Naxus and Oatwell in people with Prebiotics and Aged, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The investigators aim was to assess whether 6 weeks of oral intake of the wheat-derived prebiotic fiber arabinoxylan or oat-derived beta-glucan could improve intestinal barrier function against drug-induced barrier disruption in a general population of elderly people, in a randomized double blinded placebo-controlled… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Prebiotics, Aged
- What is being tested?
- Naxus and Oatwell
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 12 Oct 2015to 18 Dec 2015
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed by study participant
- Age ≥ 55 years
- Mentally and physically fit to complete questionnaires during the study period
Who cannot join
- Known or genic gastrointestinal disease, with strictures, malignance's and ischemia.
- Inflammatory bowel diseases (IBD)
- Participation in other clinical trials in the past three months.
- Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammatory medication (including NSAIDs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Prebiotic Supplementation on Intestinal Barrier Function in Elderly: A Randomized Placebo Controlled Clinical Trial
The investigators aim was to assess whether 6 weeks of oral intake of the wheat-derived prebiotic fiber arabinoxylan or oat-derived beta-glucan could improve intestinal barrier function against drug-induced barrier disruption in a general population of elderly people, in a randomized double blinded placebo-controlled clinical trial.
Read the detailed description
The study consisted of a 9 week clinical trial to which the study participants orally ingested two different prebiotic compounds/one placebo for a total of 6 weeks.
The primary outcome was intestinal permeability which was measured before/after indomethacin intake before starting with the prebiotic supplementation and repeated 6 weeks afterwards.
Indomethacin is an NSAID known to artificially increase the intestinal permeability. The prebiotic fibers arabinoxylan and oat-derived beta-glucan have not been investigated for their effect on intestinal permeability in older adults.
Intestinal permeability was investigated using the multi-sugar permeability test. Participants ingested a water solution containing 5 sugar probes that are taken up in different parts of the gut. These sugars are later recovered in the urine at two different time points, reflecting gastroduodenal, small intestinal and colonic permeability.
- Conditions
- Prebiotics, Aged
- Being tested
- Naxus, Oatwell, Placebo
- Keywords
- Older adults, Prebiotics, Intestinal permeability, NSAIDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaxusDietary supplement
Also called Placebo
Non-digestible polysaccharides arabinoxylan (Naxus)
OatwellDietary supplement
Non-digestible polysaccharides oat beta-glucan (Oatwell)
PlaceboDietary supplement
Maltodextrin as placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin 12 gram used as placebo Receives: Dietary Supplement: Placebo |
| Naxus | Active comparator | Naxus contains the wheat-derived prebiotic fibre Arabinoxylan Receives: Dietary Supplement: Naxus |
| Oatwell | Active comparator | Oatwell contains an oat-derived prebiotic beta-glucan fibre Receives: Dietary Supplement: Oatwell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in delta indomethacin challenged permeability at end of intervention period
In vivo multi-sugar permeability test
Measured: 6 weeks
Secondary outcomes (7)
Changes in faecal microbiota composition at end of intervention period
16S rRNA-based sequencing
Measured: 6 weeks
Changes in cytokine levels at end of intervention period
Multiplex assay for IL-1β, IL-6, IL-8, IL-10, IL-2, IL-12p70, IFN-γ and TNF-α
Measured: 6 weeks
Changes in reactive oxygen species levels at end of intervention period
FORT test for hydrogen peroxide
Measured: 6 weeks
Changes in gastrointestinal symptom questionnaire scores at end of intervention period
The Gastrointestinal Symptoms Rating Scale (GSRS) evaluates gastrointestinal (GI) symptoms based on the 5 domains diarrhoea, constipation, reflux, indigestion and abdominal pain. The symptoms are assessed with 15 items, ranging in scores 1 to 7 depending on their severity. A score of 1 represents "no problems" and score 7 represents "severe problems". The severity of symptoms may be defined as no problems (1 point), mild (1-2 points), moderate (2-4 points), and severe (4-7 points). The scores for each domain was calculated as the mean score of each corresponding item while the mean total GSRS score reflects the general severity of GI symptoms.
Measured: 6 weeks
Changes in hospital and anxiety depression scores at end of intervention period
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the psychological distress of study participants.This questionnaire consists of 14 items subdivided in two subscales for the assessment of anxiety or depression. The total score is used as a measure of general psychological distress. The minimum score is 0 and the maximum score is 21. A score > 8 on respective subscales indicates a significant level of anxiety or depression.
Measured: 6 weeks
Changes in perceived stress scale scores at end of intervention period
The perceived stress scale (PSS) consists of 10 items, including a number of direct questions about current levels of experienced stress. The respondent answers how often a certain emotion has been present during the past month. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Each item is rated on a 5-point scale ranging from never (0) to almost always (4). The questions in this scale ask about the responders feelings and thoughts during the last month. In each case the questionnaire requires the respondent to indicate by circling how often they felt or thought a certain way.
Measured: 6 weeks
Changes in quality of life questionnaire scores at end of intervention period
The EuroQol 5D-5L (EQ-5D-5L) tool consists of two parts; 5Q-5D, which includes 5 items related to wellbeing and function (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression) and the visual analogue scale, 5Q-5D-VAS, ranging from 0 to 100.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start12 Oct 2015
- Primary completion18 Dec 2015
- Study completion18 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrebioticsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study participants were allocated through block randomization into three different intervention arms that ran in parallell throughout the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Fibebiotics consortium (EU)
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert J Brummer, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336385
- Sponsor's protocol ID
- FIT
- Status last verified
- Aug 2018
- First submitted
- 14 Sep 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Prebiotic Supplementation on Intestinal Barrier Function in Elderly: A Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03336385
- Acronym / sponsor ID
- FIT
- Conditions
- Prebiotics, Aged
- Keywords
- Older adults, Prebiotics, Intestinal permeability, NSAIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Fibebiotics consortium (EU)
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 8 Nov 2017 (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.
The investigators aim was to assess whether 6 weeks of oral intake of the wheat-derived prebiotic fiber arabinoxylan or oat-derived beta-glucan could improve intestinal barrier function against drug-induced barrier disruption in a general population of elderly people, in a randomized double blinded placebo-controlled clinical trial.
Detailed description
The study consisted of a 9 week clinical trial to which the study participants orally ingested two different prebiotic compounds/one placebo for a total of 6 weeks.
The primary outcome was intestinal permeability which was measured before/after indomethacin intake before starting with the prebiotic supplementation and repeated 6 weeks afterwards.
Indomethacin is an NSAID known to artificially increase the intestinal permeability. The prebiotic fibers arabinoxylan and oat-derived beta-glucan have not been investigated for their effect on intestinal permeability in older adults.
Intestinal permeability was investigated using the multi-sugar permeability test. Participants ingested a water solution containing 5 sugar probes that are taken up in different parts of the gut. These sugars are later recovered in the urine at two different time points, reflecting gastroduodenal, small intestinal and colonic permeability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study participants were allocated through block randomization into three different intervention arms that ran in parallell throughout the study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin 12 gram used as placebo |
| Naxus | Active comparator | Dietary Supplement: NaxusNaxus contains the wheat-derived prebiotic fibre Arabinoxylan |
| Oatwell | Active comparator | Dietary Supplement: OatwellOatwell contains an oat-derived prebiotic beta-glucan fibre |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent signed by study participant
- Age ≥ 55 years
- Mentally and physically fit to complete questionnaires during the study period
Key exclusion criteria (4 listed)
- Known or genic gastrointestinal disease, with strictures, malignance's and ischemia.
- Inflammatory bowel diseases (IBD)
- Participation in other clinical trials in the past three months.
- Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammatory medication (including NSAIDs)
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 |
|---|---|---|
| NaxusAlso: PlaceboNon-digestible polysaccharides arabinoxylan (Naxus) | Dietary supplement | Naxus |
| OatwellNon-digestible polysaccharides oat beta-glucan (Oatwell) | Dietary supplement | Oatwell |
| PlaceboMaltodextrin as placebo | Dietary supplement | Placebo |
Primary outcome
Changes in delta indomethacin challenged permeability at end of intervention period
Time frame: 6 weeks
In vivo multi-sugar permeability test
7 secondary outcomes
Changes in faecal microbiota composition at end of intervention period
Time frame: 6 weeks
Changes in cytokine levels at end of intervention period
Time frame: 6 weeks
Changes in reactive oxygen species levels at end of intervention period
Time frame: 6 weeks
Changes in gastrointestinal symptom questionnaire scores at end of intervention period
Time frame: 6 weeks
Changes in hospital and anxiety depression scores at end of intervention period
Time frame: 6 weeks
Changes in perceived stress scale scores at end of intervention period
Time frame: 6 weeks
Changes in quality of life questionnaire scores at end of intervention period
Time frame: 6 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 23 Aug 2018.
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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.
Robert J Brummer, MD, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naxus and Oatwell in people with Prebiotics and Aged, run by Örebro University, Sweden at 1 site in Sweden.
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 3 inclusion and 4 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 23 Aug 2018. 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 Sweden. 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 delta indomethacin challenged permeability at end of intervention period (time frame: 6 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 23 Aug 2018.