Constipation - FunctionalNCT04086134
Physiological, Microbiological and Metabolomic Effects of Fruit Products
A study testing Fruit Products in people with Constipation - Functional, run by King's College London at 1 site in United Kingdom.
Trial summary
This study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effects on the dietary intake and quality in healthy people with constipation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Fruit Products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2019to 31 Mar 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-65 years.
- Individuals meeting the Rome IV criteria for functional constipation, in addition to having <7 bowel movements per week and hard or lumpy stools present in ⩾25% of their defecations (defined as Type 1 \& 2 of the Bristol Stool Form Scale).
- Individuals who are willing to consume fruit products for 4 weeks.
- Individuals who consume <30g of fibre per day
- Individuals with a BMI of 18.5-29.99 kg/m2.
- Individuals able to give informed consent.
Who cannot join
- Females who report to be pregnant or lactating.
- Regular consumers of the fruit products used in the intervention arm 1 (3 or more portions per week).
- Allergy, intolerance or dislike of the fruit products used in this intervention.
- Sulphite allergy or sensitivity.
- Ongoing alcohol, drug or medication abuse.
- Major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy, appendicectomy and haemorrhoidectomy.
- Medications which affect their gut physiology, function and symptoms in the last 4 weeks, and individuals who are not willing or cannot discontinue them.
- Frequent use of rescue laxatives.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE1 9NH
Zoi Katsirma, 02078484552, frugut@kcl.ac.uk
About this study
Official title: The FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products
This study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effects on the dietary intake and quality in healthy people with constipation.
- Conditions
- Constipation - Functional
- Being tested
- Fruit Products
- Keywords
- constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit ProductsOther
Fruit Products with the potential to improve constipation-related outcomes
| Study group | Role | What they receive |
|---|---|---|
| Intervention fruit products 1 | Experimental | Three servings of fruit products per day for 4 weeks. Receives: Other: Fruit Products |
| Intervention fruit products 2 | Experimental | Three servings of fruit products per day for 4 weeks. Receives: Other: Fruit Products |
| Control fruit products | Placebo comparator | Three servings of control fruit products per day for 4 weeks. Receives: Other: Fruit Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in faecal weight between baseline and week 4
Change in 7-day faecal weight
Measured: week 4
Secondary outcomes (16)
Faecal microbiome diversity
Global microbiota composition (α-diversity, β-diversity)
Measured: week 0 and 4
Faecal microbiome
Ιndividual phyla, family, genera, species and strains of the faecal gut microbiome (absolute and change).
Measured: week 0 and 4
Faecal metabolomic profile
Faecal metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
Measured: week 0 and 4
Urine metabolomic profile
Urine metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
Measured: week 0 and 4
Faecal short-chain fatty acids
Faecal short-chain fatty acids concentration (absolute and change)
Measured: week 0 and 4
Faecal water content
Faecal water content (absolute and change) measured through lyophilisation
Measured: week 0 and 4
Faecal pH
Faecal pH (absolute and change)
Measured: week 0 and 4
Stool output
Assessed using 7-day diaries and the Bristol Stool Form Scale (absolute and change)..
Measured: week 0 and 4
Individual gastrointestinal symptoms
The 7-day diaries contain a short questionnaire for each bowel movement to monitor completeness, spontaneity, straining and need for manual maneuvers. The validated Gastrointestinal Symptom Rating Scale will be used over a 7-day period
Measured: week 0 and 4
Gastrointestinal symptoms - PAC-SYM
The validated questionnaire Patient Assessment of Constipation Symptoms (PAC-SYM) will be used (absolute and change).
Measured: week 0 and 4
Gastrointestinal symptom severity questionnaire - CCCS
The validated questionnaire Cleveland Clinic Constipation Score (CCCS) will be used (absolute and change).
Measured: week 0 and 4
Dietary intake
Dietary intake (absolute and change) will be recorded in 7-day food and drink diaries
Measured: week 0 and 4
Constipation-related quality of life
Constipation-related quality of life (absolute and change) which will be measured with the condition-specific validated Patient Assessment of Constipation Quality of Life (PAC-Qol) questionnaire. PAC-QoL is a self-report 28-item tool that uses a 5-point Likert scale ranging from "Not at all" to "Extremely".
Measured: week 0 and 4
Whole and regional gut transit time/pH
Whole gut transit time and regional gut pH (absolute and change) will be assessed in a subset of participants (n=39), by using a motility capsule (SmartPill ®, Medtronic)
Measured: week 0 and 4
Acceptability of interventions
Acceptability of the interventions measured using a questionnaire that included 3- and 4-point likert scales and open-text answers
Measured: week 0 and 4
Compliance
Compliance to the study interventions will be measured using specific questions relevant to the intervention received in the food and drink diary completed at week 4, by regular phone calls with participants throughout the intervention period, and by the number of unconsumed fruit products returned by the participants after the end of the intervention.
Measured: week 0 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start25 Oct 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
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 King's College LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Kevin Whelan, MSc, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086134
- Sponsor's protocol ID
- HR-17/18-7858
- Status last verified
- Jun 2021
- First submitted
- 20 Jun 2019
- Last updated
- 22 Jun 2021
- 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 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products
- ClinicalTrials.gov ID
- NCT04086134
- Acronym / sponsor ID
- HR-17/18-7858
- Conditions
- Constipation - Functional
- Keywords
- constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Queen Mary University of London, Imperial College London
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 11 Sep 2019 (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.
This study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effects on the dietary intake and quality in healthy people with constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention fruit products 1 | Experimental | Other: Fruit ProductsThree servings of fruit products per day for 4 weeks. |
| Intervention fruit products 2 | Experimental | Other: Fruit ProductsThree servings of fruit products per day for 4 weeks. |
| Control fruit products | Placebo comparator | Other: Fruit ProductsThree servings of control fruit products per day for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18-65 years.
- Individuals meeting the Rome IV criteria for functional constipation, in addition to having <7 bowel movements per week and hard or lumpy stools present in ⩾25% of their defecations (defined as Type 1 \& 2 of the Bristol Stool Form Scale).
- Individuals who are willing to consume fruit products for 4 weeks.
- Individuals who consume <30g of fibre per day
- Individuals with a BMI of 18.5-29.99 kg/m2.
Key exclusion criteria (8 listed)
- Females who report to be pregnant or lactating.
- Regular consumers of the fruit products used in the intervention arm 1 (3 or more portions per week).
- Allergy, intolerance or dislike of the fruit products used in this intervention.
- Sulphite allergy or sensitivity.
- Ongoing alcohol, drug or medication abuse.
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 |
|---|---|---|
| Fruit ProductsFruit Products with the potential to improve constipation-related outcomes | Other | Control fruit products, Intervention fruit products 1, Intervention fruit products 2 |
Primary outcome
Change in faecal weight between baseline and week 4
Time frame: week 4
Change in 7-day faecal weight
16 secondary outcomes
Faecal microbiome diversity
Time frame: week 0 and 4
Faecal microbiome
Time frame: week 0 and 4
Faecal metabolomic profile
Time frame: week 0 and 4
Urine metabolomic profile
Time frame: week 0 and 4
Faecal short-chain fatty acids
Time frame: week 0 and 4
Faecal water content
Time frame: week 0 and 4
Faecal pH
Time frame: week 0 and 4
Stool output
Time frame: week 0 and 4
Individual gastrointestinal symptoms
Time frame: week 0 and 4
Gastrointestinal symptoms - PAC-SYM
Time frame: week 0 and 4
Gastrointestinal symptom severity questionnaire - CCCS
Time frame: week 0 and 4
Dietary intake
Time frame: week 0 and 4
Constipation-related quality of life
Time frame: week 0 and 4
Whole and regional gut transit time/pH
Time frame: week 0 and 4
Acceptability of interventions
Time frame: week 0 and 4
Compliance
Time frame: week 0 and 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- 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.
Kevin Whelan, MSc, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit Products in people with Constipation - Functional, run by King's College London at 1 site in United Kingdom.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Jun 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoi Katsirma, MSc (020 7848 4552, zoi.katsirma@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in faecal weight between baseline and week 4 (time frame: week 4). 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 Jun 2021.