Irritable Bowel SyndromeNCT02888392
The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions
A study testing Kiwifruit and Psyllium in people with Irritable Bowel Syndrome, run by Zespri International Limited at 1 site in Italy.
Trial summary
The proposed study will primarily demonstrate the efficacy of kiwifruit as a food intervention for the relief of constipation and associated symptoms in functionally constipated adults, and those with IBS-C. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Kiwifruit and Psyllium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 18 Dec 2015to 30 Jan 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The functionally constipated (FC) study participant group will be selected based on the following criteria:
- Presence of functional constipation according to ROME III diagnostic criteria*5b i. Must include two or more of the following:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations
Show all 14Show fewer
- Manual manoeuvres to facilitate at least 25% of defecations (e.g. digital evacuation, support of pelvic floor)
- Fewer than three defecations per week ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- Participants with IBS-C (mild). The diagnostic criteria * for Irritable Bowel Syndrome5a is:
- Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following:
- Improvement with defecation ii. Onset associated with a change in frequency of stool iii. Onset associated with a change in form (appearance of stool)
- Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- Discomfort means an uncomfortable sensation not described as pain. In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation for subject eligibility.
- IBS-C requires meeting the IBS criteria together with - hard or lumpy stools (Bristol Stool Form Scale 1-2) ≥ 25%, and loose or mushy stools ≤ 25% of bowel movements (Bristol Stool Form Scale 6-7).
Who cannot join
- Potential participants will be excluded if they have any alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, occult blood in stools, anaemia), anal fissures, bleeding haemorrhoids, and family history of GI cancer or IBD.
- Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal chord injury, stroke).
- All patients will be screened at recruitment for fasting blood glucose. Those with results ≥ 7.2 mmol/l will not be accepted into the trial.
- Participants with diagnosed and stable conditions requiring the use of SSRI's (selective serotonin reuptake inhibitors), tricyclates, opiates or anti-inflammatories will be permitted into the trial on condition the medication has been in use continually and the condition has been stable for > 3 months. Similarly those with stable and controlled diabetes (> 3 months) will be permitted to participate.
- Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection (trial period) will be excluded.
- Potential participants with known kiwifruit or latex allergy will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions: a Multi-country, Randomized, Cross-over Clinical Intervention
The proposed study will primarily demonstrate the efficacy of kiwifruit as a food intervention for the relief of constipation and associated symptoms in functionally constipated adults, and those with IBS-C. Secondary measures will show the consumption of kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with IBS-C.
Read the detailed description
The study is a randomised, single-blinded, cross-over design. Both target study populations (those with functional constipation, and the matched healthy control group) will complete the 16-week trial. Each study group will be randomly selected to either begin the first intervention period on the kiwifruit treatment or the psyllium treatment, and following the washout period will then receive the opposite treatment. Researchers and analysts will be blind as to as to the order of treatment individuals will receive. A dedicated treatment administrator will be assigned to provide the treatments to participants and liaise with them during the intervention phases.
All participants will be free living and required to maintain their normal dietary and lifestyle habits for the duration of the trial.
The primary outcome measure will be quantification of CSBM (complete spontaneous bowel movement). Secondary outcome measures will include additional stool frequency measures and other questionnaires.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Kiwifruit, Psyllium
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KiwifruitOther
2 green kiwifruit cultivar 'Hayward'
PsylliumDietary supplement
Also called Ispaghula, isabgol
Pysllium seed husk; ispaghula, isabgol, or psyllium, are portions of the seeds of the plant Plantago ovata, (genus Plantago), a native of India, Bangladesh and Pakistan. They are hygroscopic, which allows them to expand and become mucilaginous. Psyllium is a faecal bulking agent used to treat constipation. It absorbs liquid in the intestines, swells and forms a bulky soft stool that is easy to pass
| Study group | Role | What they receive |
|---|---|---|
| Kiwifruit intervention | Experimental | 4 week intervention treatment with 2 fresh, whole green kiwifruit per day Receives: Other: Kiwifruit |
| Psyllium intervention | Active comparator | 4 week intervention treatment with psyllium, matched for fibre content of 2 green kiwifruit / day for 4 weeks Receives: Dietary Supplement: Psyllium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Spontaneous Bowel Motions
A spontaneous bowel motion not induced by rescue medication and associated with a sense of complete evacuation
Measured: Total study duration per participant of 16 weeks. CSBM was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .
Secondary outcomes (7)
Daily Bowel Habit
Frequency of bowel movements, ease of defaecation, stool form
Measured: Total study duration per participant of 16 weeks. Daily bowel habit was assessed daily from 2 week lead-in before baseline and every day through intervention 1, wash-out, intervention 2 and for a two week follow-up period .
Weekly Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal Symptom Rating Scale
Measured: Total study duration per participant of 16 weeks. GSRS was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .
Rome III
Rome III questionnaire to establish patient group as Healthy, FC, or IBS-C
Measured: Total study duration per participant of 16 weeks. Rome III was assessed at the start of the study, 2 weeks later at baseline, and at the end of each study period i.e. after intervention 1, wash-out, intervention 2 and at the end of a 2 week follow up .
Irritable Bowel Syndrome Quality of Life (IBS-QoL) evaluation
Validated quality of life questionnaire
Measured: Total study duration per participant of 16 weeks. Rome III was assessed at baseline, and at the end of each study period i.e. after intervention 1, wash-out, and the end of intervention 2.
Profile of Mood Score (POMS)
Validated mood score questionnaire
Measured: Total study duration per participant of 16 weeks. POMS was assessed at baseline, and at the end of each study period i.e. after intervention 1, wash-out, intervention 2 and at the end of a 2 week follow up .
Irritable Bowel Syndrome severity score index (IBS-SSI)
Validated questionnaire to score severity of IBS to assign participants to correct group
Measured: IBS-SSI was completed once at enrollment
3-day Food Diary
3 day recall diet record to establish diet remains consistent throughout study
Measured: Total study duration per participant of 16 weeks. The food diary was done at baseline, and at the end of each study period i.e. after intervention 1, wash-out, and intervention 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start18 Dec 2015
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zespri International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Barbara, MD, Principal investigator, St. Orsola Hospital, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888392
- Sponsor's protocol ID
- HN1525
- Status last verified
- Jun 2017
- First submitted
- 22 Aug 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gearry R, Fukudo S, Barbara G, Kuhn-Sherlock B, Ansell J, Blatchford P, Eady S, Wallace A, Butts C, Cremon C, Barbaro MR, Pagano I, Okawa Y, Muratubaki T, Okamoto T, Fuda M, Endo Y, Kano M, Kanazawa M, Nakaya N, Nakaya K, Drummond L. Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort-Results of an International Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2023 Jun 1;118(6):1058-1068. doi: 10.14309/ajg.0000000000002124. Epub 2022 Dec 20.
PubMed 36537785
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions: a Multi-country, Randomized, Cross-over Clinical Intervention
- ClinicalTrials.gov ID
- NCT02888392
- Acronym / sponsor ID
- HN1525
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zespri International LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 5 Sep 2016 (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 proposed study will primarily demonstrate the efficacy of kiwifruit as a food intervention for the relief of constipation and associated symptoms in functionally constipated adults, and those with IBS-C. Secondary measures will show the consumption of kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with IBS-C.
Detailed description
The study is a randomised, single-blinded, cross-over design. Both target study populations (those with functional constipation, and the matched healthy control group) will complete the 16-week trial. Each study group will be randomly selected to either begin the first intervention period on the kiwifruit treatment or the psyllium treatment, and following the washout period will then receive the opposite treatment. Researchers and analysts will be blind as to as to the order of treatment individuals will receive. A dedicated treatment administrator will be assigned to provide the treatments to participants and liaise with them during the intervention phases.
All participants will be free living and required to maintain their normal dietary and lifestyle habits for the duration of the trial.
The primary outcome measure will be quantification of CSBM (complete spontaneous bowel movement). Secondary outcome measures will include additional stool frequency measures and other questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kiwifruit intervention | Experimental | Other: Kiwifruit4 week intervention treatment with 2 fresh, whole green kiwifruit per day |
| Psyllium intervention | Active comparator | Dietary Supplement: Psyllium4 week intervention treatment with psyllium, matched for fibre content of 2 green kiwifruit / day for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The functionally constipated (FC) study participant group will be selected based on the following criteria:
- Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following:
- Discomfort means an uncomfortable sensation not described as pain. In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation for subject eligibility.
- IBS-C requires meeting the IBS criteria together with - hard or lumpy stools (Bristol Stool Form Scale 1-2) ≥ 25%, and loose or mushy stools ≤ 25% of bowel movements (Bristol Stool Form Scale 6-7).
Key exclusion criteria (6 listed)
- Potential participants will be excluded if they have any alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, occult blood in stools, anaemia), anal fissures, bleeding haemorrhoids, and family history of GI cancer or IBD.
- Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal chord injury, stroke).
- All patients will be screened at recruitment for fasting blood glucose. Those with results ≥ 7.2 mmol/l will not be accepted into the trial.
- Participants with diagnosed and stable conditions requiring the use of SSRI's (selective serotonin reuptake inhibitors), tricyclates, opiates or anti-inflammatories will be permitted into the trial on condition the medication has been in use continually and the condition has been stable for > 3 months. Similarly those with stable and controlled diabetes (> 3 months) will be permitted to participate.
- Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection (trial period) will be excluded.
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 |
|---|---|---|
| Kiwifruit2 green kiwifruit cultivar 'Hayward' | Other | Kiwifruit intervention |
| PsylliumAlso: Ispaghula, isabgolPysllium seed husk; ispaghula, isabgol, or psyllium, are portions of the seeds of the plant Plantago ovata, (genus Plantago), a native of India, Bangladesh and Pakistan. They are hygroscopic, which allows them to expand and become mucilaginous. Psyllium is a faecal bulking agent used to treat constipation. It absorbs liquid in the intestines, swells and forms a bulky soft stool that is easy to pass | Dietary supplement | Psyllium intervention |
Primary outcome
Complete Spontaneous Bowel Motions
Time frame: Total study duration per participant of 16 weeks. CSBM was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .
A spontaneous bowel motion not induced by rescue medication and associated with a sense of complete evacuation
7 secondary outcomes
Daily Bowel Habit
Time frame: Total study duration per participant of 16 weeks. Daily bowel habit was assessed daily from 2 week lead-in before baseline and every day through intervention 1, wash-out, intervention 2 and for a two week follow-up period .
Weekly Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Total study duration per participant of 16 weeks. GSRS was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .
Rome III
Time frame: Total study duration per participant of 16 weeks. Rome III was assessed at the start of the study, 2 weeks later at baseline, and at the end of each study period i.e. after intervention 1, wash-out, intervention 2 and at the end of a 2 week follow up .
Irritable Bowel Syndrome Quality of Life (IBS-QoL) evaluation
Time frame: Total study duration per participant of 16 weeks. Rome III was assessed at baseline, and at the end of each study period i.e. after intervention 1, wash-out, and the end of intervention 2.
Profile of Mood Score (POMS)
Time frame: Total study duration per participant of 16 weeks. POMS was assessed at baseline, and at the end of each study period i.e. after intervention 1, wash-out, intervention 2 and at the end of a 2 week follow up .
Irritable Bowel Syndrome severity score index (IBS-SSI)
Time frame: IBS-SSI was completed once at enrollment
3-day Food Diary
Time frame: Total study duration per participant of 16 weeks. The food diary was done at baseline, and at the end of each study period i.e. after intervention 1, wash-out, and intervention 2
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 2 Jul 2017.
- Derived from this study: PubMed 36537785Gearry R, Fukudo S, Barbara G, Kuhn-Sherlock B, Ansell J, Blatchford P, Eady S, Wallace A, Butts C, Cremon C, Barbaro MR, Pagano I, Okawa Y, Muratubaki T, Okamoto T, Fuda M, Endo Y, Kano M, Kanazawa M, Nakaya N, Nakaya K, Drummond L. Consumption of 2 Green Kiwifruits Daily Improves Constipation and Abdominal Comfort-Results of an International Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2023 Jun 1;118(6):1058-1068. doi: 10.14309/ajg.0000000000002124. Epub 2022 Dec 20.
- Individual participant dataSharing planned: Undecided
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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.
Giovanni Barbara, MD principal investigator
St. Orsola Hospital, University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kiwifruit and Psyllium in people with Irritable Bowel Syndrome, run by Zespri International Limited 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 14 inclusion and 6 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 2 Jul 2017. 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. 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?
Complete Spontaneous Bowel Motions (time frame: Total study duration per participant of 16 weeks. CSBM was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888392, which also lists 1 linked publication.
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 2 Jul 2017.