Functional ConstipationPDX-TransitNCT01540669
Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time
A study testing Polydextrose, low dose, Polydextrose, medium dose and Polydextrose, high dose in people with Functional Constipation, run by Danisco at 1 site in Italy.
Trial summary
The aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Polydextrose, low dose, Polydextrose, medium dose and Polydextrose, high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Nov 2013
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
- Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
- Must meet 2 or more of the following criteria:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
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- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations
- Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- Fewer than three defecations per week
- Loose stools are rarely present without the use of laxatives
- Insufficient criteria for irritable bowel syndrome
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
- Consent to the study and willing to comply with study product and methods
- Willingness to maintain a stable diet throughout the study
- Consistent use and dose of chronic medication, if any, in the past 30 days
Who cannot join
- Major gastrointestinal complication (e.g. Crohn"s disease, colitis, celiac disease)
- Febrile diverticulitis within 1 year of screening
- Pelvic floor dysfunction
- Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results
- Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, removal of gall bladder
- Clinically significant underlying systemic illness that may preclude the subject"s ability to complete the trial or that may confound the study outcomes
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- Any clinically relevant abnormalities in the physical examination or in laboratory variables before entry into the study
- Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening
- Laxative, fiber supplement, or other constipation medication (e.g. prokinetic drugs) use within 2 weeks of screening
- Antibiotic use within 1 month of enrollment
- Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#- antagonists, antacids with magnesium or aluminum, or diarrhea medication)
- Anticipated major dietary or exercise changes during the study period
- Known allergies to any substance in the study product
- Pregnant or lactating female, or pregnancy planned during study period
- Eating disorder
- History of alcohol, drug, or medication abuse
- Participation in another study with any investigational product within 3 months of screening
- Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-ranging Efficacy of 2-week Polydextrose Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebocontrolled Trial
The aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.
Read the detailed description
Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
- Conditions
- Functional Constipation
- Being tested
- Polydextrose, low dose, Polydextrose, medium dose, Polydextrose, high dose, Placebo powder
- Keywords
- constipation, functional constipation, polydextrose, whole gut transit time
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polydextrose, low doseDietary supplement
4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
Polydextrose, medium doseDietary supplement
8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
Polydextrose, high doseDietary supplement
12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
Placebo powderDietary supplement
Placebo powder will be mixed with beverage and consumed once per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Polydextrose, low dose | Active comparator | Polydextrose, low dose Receives: Dietary Supplement: Polydextrose, low dose |
| Polydextrose, medium dose | Active comparator | Polydextrose, medium dose Receives: Dietary Supplement: Polydextrose, medium dose |
| Polydextrose, high dose | Active comparator | Polydextrose, high dose Receives: Dietary Supplement: Polydextrose, high dose |
| Placebo powder | Placebo comparator | Placebo powder Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole gut transit time
Measured: 2 weeks
Secondary outcomes (12)
Patient assessment of constipation quality of life
Measured: 2 weeks
Patient assessment of constipation symptoms
Measured: 2 weeks
Bowel Function Index
Measured: 2 weeks
Adequate relief of constipation
Measured: 2 weeks
Bowel movement frequency
Measured: 2 weeks
Stool consistency
Measured: 2 weeks
Degree of straining
Measured: 2 weeks
Subjective assessment of bowel emptying
Measured: 2 weeks
Abdominal discomfort/bloating
Measured: 2 weeks
Overall product satisfaction
Measured: 2 weeks
Blood and urine safety analysis
Measured: 2 weeks
Adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- Silvio Danese, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540669
- Sponsor's protocol ID
- Q-PRE-0111-CLI-007
- Acronym
- PDX-Transit
- Status last verified
- Jan 2016
- First submitted
- 23 Feb 2012
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Terminated
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-ranging Efficacy of 2-week Polydextrose Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebocontrolled Trial
- ClinicalTrials.gov ID
- NCT01540669
- Acronym / sponsor ID
- PDX-Transit / Q-PRE-0111-CLI-007
- Conditions
- Functional Constipation
- Keywords
- constipation, functional constipation, polydextrose, whole gut transit time
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 59 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Mar 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Feb 2012 (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 aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.
Detailed description
Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polydextrose, low dose | Active comparator | Dietary Supplement: Polydextrose, low dosePolydextrose, low dose |
| Polydextrose, medium dose | Active comparator | Dietary Supplement: Polydextrose, medium dosePolydextrose, medium dose |
| Polydextrose, high dose | Active comparator | Dietary Supplement: Polydextrose, high dosePolydextrose, high dose |
| Placebo powder | Placebo comparator | Dietary Supplement: Placebo powderPlacebo powder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age between 18 and 70 years
- Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
- Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
Key exclusion criteria (18 listed)
- Major gastrointestinal complication (e.g. Crohn"s disease, colitis, celiac disease)
- Febrile diverticulitis within 1 year of screening
- Pelvic floor dysfunction
- Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results
- Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, removal of gall bladder
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 |
|---|---|---|
| Polydextrose, low dose4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks | Dietary supplement | Polydextrose, low dose |
| Polydextrose, medium dose8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks | Dietary supplement | Polydextrose, medium dose |
| Polydextrose, high dose12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks | Dietary supplement | Polydextrose, high dose |
| Placebo powderPlacebo powder will be mixed with beverage and consumed once per day for 2 weeks | Dietary supplement | Placebo powder |
Primary outcome
Whole gut transit time
Time frame: 2 weeks
12 secondary outcomes
Patient assessment of constipation quality of life
Time frame: 2 weeks
Patient assessment of constipation symptoms
Time frame: 2 weeks
Bowel Function Index
Time frame: 2 weeks
Adequate relief of constipation
Time frame: 2 weeks
Bowel movement frequency
Time frame: 2 weeks
Stool consistency
Time frame: 2 weeks
Degree of straining
Time frame: 2 weeks
Subjective assessment of bowel emptying
Time frame: 2 weeks
Abdominal discomfort/bloating
Time frame: 2 weeks
Overall product satisfaction
Time frame: 2 weeks
Blood and urine safety analysis
Time frame: 2 weeks
Adverse events
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Individual participant dataSharing planned: No. Terminated
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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.
Silvio Danese, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polydextrose, low dose, Polydextrose, medium dose and Polydextrose, high dose in people with Functional Constipation, run by Danisco at 1 site in Italy.
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 16 inclusion and 18 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: stopped early, as of the sponsor's last update on 22 Jan 2016. 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 Italy. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Whole gut transit time (time frame: 2 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 22 Jan 2016.