Constipation - FunctionalTYPHOON-02NCT05714410
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG Compared to Placebo
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 as Compared to Placebo (Typhoon 2) 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIreland
- Study dates
- 25 Jan 2023to 19 Jan 2024
- 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.
- Adapted Rome IV Criteria of functional constipation* or IBSconstipation** for a minimum of 3 months
- 1-2 SBM/week and at least 1 of the following at least 30% of the time:
- Bristol stool scale 1-2
- Straining
- Sense of incomplete evacuation
Show all 11Show fewer
- Sense of stool blockage
- Need of digital maneuvers
- Subjects with IBS-C: the above constipation criteria + abdominal pain are allowed.
- 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.
- Organic chronic gastrointestinal disease or complication (such as, but not limited to, Inflammatory Bowel Disease, Microscopic colitis, Eosinophilic gastroenteritis, Radiation-related enterocolitis, Coeliac disease).
- Subjects with a diagnosed food allergy or hypersensitive to any of the components of the study product.
- Subjects with chronic diarrhea.
- Active peptic ulcer.
- Major gastrointestinal or colonic surgery (such as, gastric bypass or any other obesity or metabolic interventions including endoscopic procedures or devices, any gastro-intestinal or colonic resection); cholecystectomy and appendectomy are allowed.
Show all 18Show fewer
- Neurologic or other clinically significant comorbid diseases that may affect gastrointestinal function, such as multiple sclerosis, spinal cord injury or Hirschsprung disease.
- 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 clinically significant (as per physician judgement) co-morbid illnesses such as cardiovascular, endocrine (e.g. hypothyroidism, diabetes), renal, or other chronicdisease (e.g. reduced mobility or increased fragility).
- Active alcohol, drug, or medication abuse (as per clinician judgement).
- Self-reported symptoms suggestive of pelvic organ prolapse as per clinician judgement, 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 hemorrhoids.
- Any clinically relevant abnormalities detected during the physical examination or any 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.
- Regular (i.e. daily or weekly) use of PHGG within 6 months of screening.
- Participation in another study with any investigational product within 6 months of randomization for drug study and within 2 months of randomization for a nutritional study.
- Investigator believes that the participant is physically or mentally unfit to participate in the trial.
- Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator.
- Any participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
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 As Compared to Placebo (Typhoon 2)
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults With Constipation as Compared to Placebo (Typhoon 2)
- Conditions
- Constipation - Functional
- Being tested
- PHGG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHGGDietary supplement
PHGG
| Study group | Role | What they receive |
|---|---|---|
| PHGG fiber | Active comparator | Partially Hydrolyzed Guar Gum (PHGG) in powder formulation, is to be consumed orally adding water or juice. One serving per day. Receives: Dietary Supplement: PHGG |
| Placebo Maltodextrin | Placebo comparator | Maltodextrin in powder formulation is to be consumed orally adding water or juice. One serving per day. Receives: Dietary Supplement: PHGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spontaneous Bowel Movements
Change in mean weekly frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to end of treatment period. Frequency will be defined as the mean weekly number of SBM during the 2-week run-in period prior to V0, for baseline, and during the final 2 weeks of the intervention period, for end of treatment.
Measured: 6 weeks
Secondary outcomes (3)
Change in frequency of Complete Spontaneous Bowel Movements
Change in mean weekly frequency of Complete Spontaneous Bowel Movements (CSBM) as measured by the daily bowel diary, from baseline to the end of treatment period.
Measured: 6 weeks
Change in stool consistency
Change in stool consistency as measured by the Bristol stool scale, from baseline to end of intervention. The minimum and maximum values are 1 to 7. The extremes scores mean worse outcome. The middle or the scale mean the better outcome.
Measured: 6 weeks
Change in constipation related symptoms
Change in constipation related symptoms from baseline to end of intervention as measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. The minimum and maximum values are 1 to 48. The higher score means worse outcome.
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 posted6 Feb 2023
- Study start25 Jan 2023
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
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
- 160 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
- NCT05714410
- Sponsor's protocol ID
- 22.08.CLI
- Acronym
- TYPHOON-02
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2023
- Last updated
- 19 Sep 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 19 Sep 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 As Compared to Placebo (Typhoon 2)
- ClinicalTrials.gov ID
- NCT05714410
- Acronym / sponsor ID
- TYPHOON-02 / 22.08.CLI
- Conditions
- Constipation - Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 6 Feb 2023 (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 as Compared to Placebo (Typhoon 2)
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: PHGGPartially Hydrolyzed Guar Gum (PHGG) in powder formulation, is to be consumed orally adding water or juice. One serving per day. |
| Placebo Maltodextrin | Placebo comparator | Dietary Supplement: PHGGMaltodextrin in powder formulation is to be consumed orally adding water or juice. One serving per day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men or women aged 18-75.
- Adapted Rome IV Criteria of functional constipation* or IBSconstipation** for a minimum of 3 months
- 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.
Key exclusion criteria (18 listed)
- Pregnant women or breastfeeding.
- Organic chronic gastrointestinal disease or complication (such as, but not limited to, Inflammatory Bowel Disease, Microscopic colitis, Eosinophilic gastroenteritis, Radiation-related enterocolitis, Coeliac disease).
- Subjects with a diagnosed food allergy or hypersensitive to any of the components of the study product.
- Subjects with chronic diarrhea.
- Active peptic ulcer.
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, Placebo Maltodextrin |
Primary outcome
Change in Spontaneous Bowel Movements
Time frame: 6 weeks
Change in mean weekly frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to end of treatment period. Frequency will be defined as the mean weekly number of SBM during the 2-week run-in period prior to V0, for baseline, and during the final 2 weeks of the intervention period, for end of treatment.
3 secondary outcomes
Change in frequency of Complete Spontaneous Bowel Movements
Time frame: 6 weeks
Change in stool consistency
Time frame: 6 weeks
Change in constipation related symptoms
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Constipation - Functional
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
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 11 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: finished, as of the sponsor's last update on 19 Sep 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?
Change in Spontaneous Bowel Movements (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 19 Sep 2024.