Constipation - FunctionalTYPHOONNCT04587635
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG in Adults with Constipation
A study testing PHGG in people with Constipation - Functional, run by Société des Produits Nestlé (SPN) at 1 site in Ireland.
Trial summary
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- PHGG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteIreland
- Study dates
- 16 Sep 2020to 5 Nov 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18-75, inclusive.
- Self-reported symptoms of constipation for a minimum of 3 months.
- Constipation symptoms according to the adapted Rome IV Diagnostic Questionnaire for Adults for Functional Constipation (Appendix 2) administered at screening.
- Cleveland Clinic constipation score (CCCS) of 8-20.
- Low-moderate fiber intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fiber Screener completed by site personnel.
- Ability to understand the participant information sheet and instructions, and able to provide informed consent.
- Access to a suitable smartphone device (Android or iOS) with ability to download and complete the study e-Diary daily for the duration of the trial.
Who cannot join
- Pregnant women or breastfeeding.
- Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Ulcerative Colitis, Coeliac disease, chronic diarrhoea).
- Any clinically relevant abnormalities in the screening visit physical examination or alarm features in the medical history such as sudden unintentional weight loss (>10% in 3 months), frequent rectal bleeding not caused by anal fissures or hemorrhoids, recent change in bowel habit (<3 months), severe abdominal pain and stool positive for occult blood.
- Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendectomy.
- Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease.
- Chronic usage of any medication that in the opinion of the investigator would impact gut motility two weeks prior to the initial administration of study product or up to a minimum of 5 times the half-life of the medication if it has a long half-life.
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- Illness that may preclude the participant's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in >2 weeks inability to work in the 3 months before the study start.
- Participants with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility).
- Ongoing alcohol, drug, or medication abuse (anamnesis only).
- Self-reported symptoms of pelvic organ prolapse, such as feeling of pressure or fullness in the pelvic area, intra vaginal discomfort, painful intercourse and urinary problems.
- Moderate or severe active local anorectal problems such as recurrent anal fissures, frequent bleeding, large prolapsing haemorrhoids.
- Regular use of fiber (e.g. Fybogel, Lactulose) (i.e. no more than 1 standard dose) over the week prior to the screening visit and no more than 6 standard doses in the past 1 month prior to the screening visit.
- Consumption of any type of yoghurts or probiotic-containing products, i.e. any commercially available product specified as containing Lactobacillus, Bifidobacteria, Streptococcus, Saccharomyces such as Activia, Actimel, Yakult, in the 4 weeks prior to randomization (V0).
- Participation in another study with any investigational product within 6 months of screening.
- Participation in another constipation trial in the past year.
- Investigator believes that the participant is physically or mentally unfit to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation
- Conditions
- Constipation - Functional
- Being tested
- PHGG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHGGDietary supplement
PHGG
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| PHGG fiber | Active comparator | PHGG Fiber Receives: Dietary Supplement: PHGG |
| Placebo Maltodextrin | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBM
Change in mean frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to Week 6 in the treatment group compared to placebo. Frequency will be defined as the mean number of SBM for the 2-week run-in period prior to V0 and the final 2-week period of the intervention period.
Measured: Baseline to end of treatment, up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start16 Sep 2020
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Muckley, FRCPI, Principal investigator, Altantia Food Clinical Trial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587635
- Sponsor's protocol ID
- 19.19.CLI
- Acronym
- TYPHOON
- Status last verified
- Oct 2024
- First submitted
- 24 Sep 2020
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation
- ClinicalTrials.gov ID
- NCT04587635
- Acronym / sponsor ID
- TYPHOON / 19.19.CLI
- Conditions
- Constipation - Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 14 Oct 2020 (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.
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHGG fiber | Active comparator | Dietary Supplement: PHGGPHGG Fiber |
| Placebo Maltodextrin | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged 18-75, inclusive.
- Self-reported symptoms of constipation for a minimum of 3 months.
- Constipation symptoms according to the adapted Rome IV Diagnostic Questionnaire for Adults for Functional Constipation (Appendix 2) administered at screening.
- Cleveland Clinic constipation score (CCCS) of 8-20.
- Low-moderate fiber intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fiber Screener completed by site personnel.
Key exclusion criteria (16 listed)
- Pregnant women or breastfeeding.
- Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Ulcerative Colitis, Coeliac disease, chronic diarrhoea).
- Any clinically relevant abnormalities in the screening visit physical examination or alarm features in the medical history such as sudden unintentional weight loss (>10% in 3 months), frequent rectal bleeding not caused by anal fissures or hemorrhoids, recent change in bowel habit (<3 months), severe abdominal pain and stool positive for occult blood.
- Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendectomy.
- Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease.
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 |
|---|---|---|
| PHGGPHGG | Dietary supplement | PHGG fiber |
| PlaceboMaltodextrin | Dietary supplement | Placebo Maltodextrin |
Primary outcome
SBM
Time frame: Baseline to end of treatment, up to 6 weeks.
Change in mean frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to Week 6 in the treatment group compared to placebo. Frequency will be defined as the mean number of SBM for the 2-week run-in period prior to V0 and the final 2-week period of the intervention period.
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 21 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Martin Muckley, FRCPI principal investigator
Altantia Food Clinical Trial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHGG in people with Constipation - Functional, run by Société des Produits Nestlé (SPN) at 1 site in Ireland.
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 16 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 21 Oct 2024. 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 Ireland. 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?
SBM (time frame: Baseline to end of treatment, up to 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 21 Oct 2024.