Functional DyspepsiaPhase 1NCT01021475
Does Visceral Manipulation Works in Treating Functional Dyspepsia?
A Phase 1 study testing Visceral Manipulation and PPIs and/or Domperidone in people with Functional Dyspepsia, run by International College of Osteopathic Medicine at 1 site in Italy.
Trial summary
The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy. Null hypothesis is that VM does not influence FD symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Visceral Manipulation and PPIs and/or Domperidone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Nov 2010
- Phase
- Phase 1
- 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
- Clinical diagnosis of Functional Dyspepsia
Who cannot join
- Diabetes Mellitus
- Mental disturbance
- Thyroid gland dysfunction
- Intestinal, liver and biliary tract disease
- Concurrent medications that could interact with GI function
- Positive Helicobacter Pylori status
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ambulatori Comunali di Cavenago Brianza
Cavenago di Brianza, Milano, 20040
Massimo Rossi, DO B.Sc (student), 0039 3929517349, massimo@rossimassimo.com
About this study
Official title: Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study
The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy.
Null hypothesis is that VM does not influence FD symptoms.
Read the detailed description
50 patients with Functional Dyspepsia (FD) diagnosed by General Practitioners are randomized in two therapy group: 1) drug only group and 2) drug + Visceral Manipulation group. Group 1 receive drug therapy for 4 weeks, Group 2 receive drug therapy for 4 weeks and 4 Visceral Manipulation visits with weekly frequency (visit 1 at day 1 of drug therapy). FD symptoms are recorded with VAS at baseline and after 1 and 4 weeks of therapy, and after 8 weeks (4 weeks after the finish of all therapies).
- Conditions
- Functional Dyspepsia
- Being tested
- Visceral Manipulation, PPIs and/or Domperidone
- Keywords
- Functional Dyspepsia, Visceral Manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral ManipulationProcedure or surgery
Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks and 4 VM visits with weekly frequency with first VM visit at day 1 of drug therapy.
PPIs and/or DomperidoneDrug
Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Usual drug FD therapy + Visceral Manipulation | Experimental | Not described Receives: Procedure: Visceral Manipulation |
| Usual drug FD therapy | Active comparator | Not described Receives: Drug: PPIs and/or Domperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning
Measured: baseline, 1, 4 and 8 weeks after therapy start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Rossi Massimo, DO B.Sc (student), Principal investigator, International College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021475
- Sponsor's protocol ID
- VM-01
- Status last verified
- Nov 2009
- First submitted
- 27 Nov 2009
- Last updated
- 30 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Visceral Manipulation Works in Treating Functional Dyspepsia? A Randomized Study
- ClinicalTrials.gov ID
- NCT01021475
- Acronym / sponsor ID
- VM-01
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia, Visceral Manipulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- International College of Osteopathic MedicineUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (estimated)
- First posted
- 30 Nov 2009 (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 goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy.
Null hypothesis is that VM does not influence FD symptoms.
Detailed description
50 patients with Functional Dyspepsia (FD) diagnosed by General Practitioners are randomized in two therapy group: 1) drug only group and 2) drug + Visceral Manipulation group. Group 1 receive drug therapy for 4 weeks, Group 2 receive drug therapy for 4 weeks and 4 Visceral Manipulation visits with weekly frequency (visit 1 at day 1 of drug therapy). FD symptoms are recorded with VAS at baseline and after 1 and 4 weeks of therapy, and after 8 weeks (4 weeks after the finish of all therapies).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual drug FD therapy + Visceral Manipulation | Experimental | Procedure: Visceral Manipulation |
| Usual drug FD therapy | Active comparator | Drug: PPIs and/or Domperidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Functional Dyspepsia
Key exclusion criteria (6 listed)
- Diabetes Mellitus
- Mental disturbance
- Thyroid gland dysfunction
- Intestinal, liver and biliary tract disease
- Concurrent medications that could interact with GI function
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 |
|---|---|---|
| Visceral ManipulationUsual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks and 4 VM visits with weekly frequency with first VM visit at day 1 of drug therapy. | Procedure or surgery | Usual drug FD therapy + Visceral Manipulation |
| PPIs and/or DomperidoneUsual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks | Drug | Usual drug FD therapy |
Primary outcome
FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning
Time frame: baseline, 1, 4 and 8 weeks after therapy start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2009.
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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.
Rossi Massimo, DO B.Sc (student) principal investigator
International College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Visceral Manipulation and PPIs and/or Domperidone in people with Functional Dyspepsia, run by International College of Osteopathic Medicine 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 1 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: status not confirmed, as of the sponsor's last update on 30 Nov 2009. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Massimo Rossi, DO B.Sc (Student) (00393929517349, massimo@rossimassimo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning (time frame: baseline, 1, 4 and 8 weeks after therapy start). 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 30 Nov 2009.