Healthy VolunteersNCT05046743
Intestinal Dysmotility: Effect of Colonic Load
A study testing Colonic gas load in people with Healthy Volunteers, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Abnormal motility patterns in the jejunum can be detected in patients with prominent colonic distension, and it is not clear whether these abnormalities reflect a primary jejunal dysfunction or are due to a reflex distortion. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Colonic gas load
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 30 May 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No digestive symptoms
Who cannot join
- Organic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intestinal Dysmotility in Patients With Functional Digestive Symptoms
Abnormal motility patterns in the jejunum can be detected in patients with prominent colonic distension, and it is not clear whether these abnormalities reflect a primary jejunal dysfunction or are due to a reflex distortion. The aim of the study is to determine the effect of colonic filling on jejunal postprandial motility using high-resolution manometry.
Healthy subjects will be studied following a controlled, parallel, randomized, single-blind experimental design. On the study day, nutrients will be continuously infused in the proximal jejunum (2 Kcal/min) during a 2-h period to induce a steady-state postprandial motor pattern. Jejunal motility will be concomitantly recorded using a water-perfused, high-resolution manometry catheter. After 1 hour of postprandial recording (basal period), a gas mixture will be infused during 7.5 minutes via a rectal tube (720 mL or sham infusion), and jejunal motility will be recorded for another hour.
- Conditions
- Healthy Volunteers
- Being tested
- Colonic gas load, Sham load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic gas loadOther
Colonic infusion of gas via an anal cannula
Sham loadOther
Sham infusion of gas via an anal cannula
| Study group | Role | What they receive |
|---|---|---|
| Colonic gas load | Experimental | Not described Receives: Other: Colonic gas load |
| Sham | Sham comparator | Not described Receives: Other: Sham load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel contractility
Number of contractions
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Feb 2021
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046743
- Sponsor's protocol ID
- PR(AG)56/2018B
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- 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 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Dysmotility in Patients With Functional Digestive Symptoms
- ClinicalTrials.gov ID
- NCT05046743
- Acronym / sponsor ID
- PR(AG)56/2018B
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 16 Sep 2021 (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.
Abnormal motility patterns in the jejunum can be detected in patients with prominent colonic distension, and it is not clear whether these abnormalities reflect a primary jejunal dysfunction or are due to a reflex distortion. The aim of the study is to determine the effect of colonic filling on jejunal postprandial motility using high-resolution manometry.
Healthy subjects will be studied following a controlled, parallel, randomized, single-blind experimental design. On the study day, nutrients will be continuously infused in the proximal jejunum (2 Kcal/min) during a 2-h period to induce a steady-state postprandial motor pattern. Jejunal motility will be concomitantly recorded using a water-perfused, high-resolution manometry catheter. After 1 hour of postprandial recording (basal period), a gas mixture will be infused during 7.5 minutes via a rectal tube (720 mL or sham infusion), and jejunal motility will be recorded for another hour.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonic gas load | Experimental | Other: Colonic gas load |
| Sham | Sham comparator | Other: Sham load |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No digestive symptoms
Key exclusion criteria (1 listed)
- Organic diseases
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 |
|---|---|---|
| Colonic gas loadColonic infusion of gas via an anal cannula | Other | Colonic gas load |
| Sham loadSham infusion of gas via an anal cannula | Other | Sham |
Primary outcome
Small bowel contractility
Time frame: 10 minutes
Number of contractions
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 29 Sep 2021.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonic gas load in people with Healthy Volunteers, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 1 inclusion and 1 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 29 Sep 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 Spain. 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?
Small bowel contractility (time frame: 10 minutes). 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 29 Sep 2021.