Gastro-oesophageal Reflux DiseasePhase 2NCT06317675
Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease
A Phase 2 study testing Osteopathic manipulative treatment (OMT) in people with Gastro-oesophageal Reflux Disease, run by Studio Osteopatico Busto Arsizio at 1 site in Italy.
Trial summary
To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastro-oesophageal Reflux Disease
- What is being tested?
- Osteopathic manipulative treatment (OMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 18 Feb 2024to 11 Jan 2026
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Retrosternal burning sensation and/or regurgitation
- Diagnosis of reflux with any methodology
- Duration of symptoms for more than 3 months
- Taking short or long-term proton pump inhibitors (as needed, treatment start date and expected end date, mg, drug name)
- With or without esophagitis
- With or without hiatal hernia
- With or without helicobacter pylori
- GERDQ questionnaire > 8 points
Who cannot join
- neoplastic pathologies
- patients who have undergone surgery for GERD
- systemic pathologies (rheumatic, infectious conditions, feverish state, vascular alterations, endocrine diseases including diabetes, metabolic and neoplastic syndromes),
- patients already undergoing manipulative therapy for reflux
- patients with active gastric ulcers
- congenital or acquired immune diseases
Show all 11Show fewer
- allergic state of any kind
- pregnancy
- use of intrauterine device
- patients undergoing corticosteroid therapy
- patients already subjected to manual/respiratory therapy in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteopathic Manipulative Treatment for Patients Affected by Symptoms Related to Gastro-oesophageal Reflux Disease
To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)
- Conditions
- Gastro-oesophageal Reflux Disease
- Being tested
- Osteopathic manipulative treatment (OMT)
- Keywords
- GERD, Osteopathic manipulative treatment, OMT, Manual therapy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatment (OMT)Other
Also called Manipulative treatment, Manual therapy
Manual therapy on different area of the body.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic manipulative treatment (OMT) | Experimental | Participants will receive four OMTs at week 1, 2, 4 and 8. Joint mobilization techniques for ribs, cervical and dorsal spine, as well as visceral treatment, soft-tissue release on diaphragm and abdominal wall will be used. Receives: Other: Osteopathic manipulative treatment (OMT) |
| OMT + breathing exercises. | Active comparator | This group will receive OMTs and five breathing exercises to perform daily at home. A recorded video of the exercises will be provided to participants in this group. Receives: Other: Osteopathic manipulative treatment (OMT) |
| Control | No intervention | Usual care group (PPI or reflux suppressant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in GERD-HRQL
best possible score: 0, worst possible score: 50
Measured: At week 2, 4 an 8.
Adverse effects
Type and number.
Measured: At week 2, 4 and through study completion (8 weeks)
Secondary outcomes (2)
Exercise adherence
number of exercises per day performed by participants in OMT + exercise group.
Measured: through study completion (8 weeks)
Change in drugs use
Types, number and frequency of drug assumptions (such as PPI and other oral suspensions)
Measured: At week 2, 4 and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start18 Feb 2024
- Primary completion11 Jan 2026
- Study completion11 Jan 2026
Why it stopped: Adherence and recruitment issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-oesophageal Reflux DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studio Osteopatico Busto Arsizio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317675
- Sponsor's protocol ID
- ct9873
- Status last verified
- Jul 2026
- First submitted
- 29 Feb 2024
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment for Patients Affected by Symptoms Related to Gastro-oesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT06317675
- Acronym / sponsor ID
- ct9873
- Conditions
- Gastro-oesophageal Reflux Disease
- Keywords
- GERD, Osteopathic manipulative treatment, OMT, Manual therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adherence and recruitment issues.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Studio Osteopatico Busto ArsizioUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 11 Jan 2026 (actual)
- Study completion
- 11 Jan 2026 (actual)
- First posted
- 19 Mar 2024 (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.
To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteopathic manipulative treatment (OMT) | Experimental | Other: Osteopathic manipulative treatment (OMT)Participants will receive four OMTs at week 1, 2, 4 and 8. Joint mobilization techniques for ribs, cervical and dorsal spine, as well as visceral treatment, soft-tissue release on diaphragm and abdominal wall will be used. |
| OMT + breathing exercises. | Active comparator | Other: Osteopathic manipulative treatment (OMT)This group will receive OMTs and five breathing exercises to perform daily at home. A recorded video of the exercises will be provided to participants in this group. |
| Control | No intervention | –Usual care group (PPI or reflux suppressant) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Retrosternal burning sensation and/or regurgitation
- Diagnosis of reflux with any methodology
- Duration of symptoms for more than 3 months
- Taking short or long-term proton pump inhibitors (as needed, treatment start date and expected end date, mg, drug name)
- With or without esophagitis
Key exclusion criteria (11 listed)
- neoplastic pathologies
- patients who have undergone surgery for GERD
- systemic pathologies (rheumatic, infectious conditions, feverish state, vascular alterations, endocrine diseases including diabetes, metabolic and neoplastic syndromes),
- patients already undergoing manipulative therapy for reflux
- patients with active gastric ulcers
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 |
|---|---|---|
| Osteopathic manipulative treatment (OMT)Also: Manipulative treatment, Manual therapyManual therapy on different area of the body. | Other | OMT + breathing exercises., Osteopathic manipulative treatment (OMT) |
Primary outcome
Mean change in GERD-HRQL
Time frame: At week 2, 4 an 8.
best possible score: 0, worst possible score: 50
Adverse effects
Time frame: At week 2, 4 and through study completion (8 weeks)
Type and number.
2 secondary outcomes
Exercise adherence
Time frame: through study completion (8 weeks)
Change in drugs use
Time frame: At week 2, 4 and 8.
Results and safety
The study was stopped early (reason given: Adherence and recruitment issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- 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.
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 Phase 2 study testing Osteopathic manipulative treatment (OMT) in people with Gastro-oesophageal Reflux Disease, run by Studio Osteopatico Busto Arsizio 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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 7 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Adherence and recruitment issues.). Results are not available in the source record.
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?
Mean change in GERD-HRQL (time frame: At week 2, 4 an 8.). The study lists 2 primary outcomes in all. 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 7 Jul 2026.