Recurrent Mouth UlcersPhase 2NCT01831453
Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients
A Phase 2 study testing omega-3 in people with Recurrent Mouth Ulcers, run by October 6 University at 1 site in Egypt.
Trial summary
The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Recurrent Mouth Ulcers
- What is being tested?
- omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2012to May 2013
- 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 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients older than 13 years of age
- Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter.
- History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month.
- Normal sense of pain, without anesthesia or paresthesia.
- Willingness to participate and sign the informed consent.
Who cannot join
- 1- Concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions.
- 2- Pregnancy and lactation. 3- Ulcers as a manifestation of systemic disorders such as Ulcerative Colitis, Crohn's disease, Behçet's syndrome or serious anemia.
- 4- Treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry.
- 5- Treatment of the current ulcer with any topical or systemic medication. 6- Attendance of any other clinical trials prior to 3 months of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers
Read the detailed description
In this study, we tested the hypothesis that the administration of omega 3 improve the quality of life in patients suffering recurrent oral ulceration and improve associated symptoms of pain in addition to reduction of ulcers episode.
- Conditions
- Recurrent Mouth Ulcers
- Being tested
- omega-3, placebo
- Keywords
- omega-3, recurrent aphthous stomatitis, quality of life
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3Drug
Also called fish oil
polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months
placeboDrug
Also called isopropylmyristate oil
soft gelatinous capsules filled with isopropylmyristate oil
| Study group | Role | What they receive |
|---|---|---|
| isopropylmyristate oil | Placebo comparator | placebo Soft gelatinous capsules filled with isopropylmyristate oil Receives: Drug: placebo |
| experimental | Active comparator | omega-3 1 gram three times daily for 6 months Receives: Drug: omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Measurement of oral health related quality of life (OHR-QoL),this parameter was carried out at baseline, and at 6 months of the study using the Arabic version of oral health impact profile-14 (OHIP-14) questionnaire.
Measured: six months
Secondary outcomes (3)
Pain associated with the ulcers
The measurements for treatment effectiveness included evaluation of pain associated with the ulcer(s) by means of visual analogue scales (VAS).
Measured: Six months
Duration of ulcers episode
The time needed for the ulcer to heal
Measured: Six months
The monthly number of ulcer outbreaks
The number of ulcers appears monthly in the mouth
Measured: Monthly for six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
- Study completionMay 2013 (estimated)
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 Recurrent Mouth UlcersStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Amr Moustafa Elkhouli, October 6 University
- Investigators
- Amr M Elkhouli, ass prof, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831453
- Sponsor's protocol ID
- Dr. Amr Elkhouli 1962
- Status last verified
- Apr 2013
- First submitted
- 5 Apr 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hjorth E, Zhu M, Toro VC, Vedin I, Palmblad J, Cederholm T, Freund-Levi Y, Faxen-Irving G, Wahlund LO, Basun H, Eriksdotter M, Schultzberg M. Omega-3 fatty acids enhance phagocytosis of Alzheimer's disease-related amyloid-beta42 by human microglia and decrease inflammatory markers. J Alzheimers Dis. 2013;35(4):697-713. doi: 10.3233/JAD-130131.
PubMed 23481688
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
- ClinicalTrials.gov ID
- NCT01831453
- Acronym / sponsor ID
- Dr. Amr Elkhouli 1962
- Conditions
- Recurrent Mouth Ulcers
- Keywords
- omega-3, recurrent aphthous stomatitis, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 15 Apr 2013 (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 study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers
Detailed description
In this study, we tested the hypothesis that the administration of omega 3 improve the quality of life in patients suffering recurrent oral ulceration and improve associated symptoms of pain in addition to reduction of ulcers episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isopropylmyristate oil | Placebo comparator | Drug: placeboplacebo Soft gelatinous capsules filled with isopropylmyristate oil |
| experimental | Active comparator | Drug: omega-3omega-3 1 gram three times daily for 6 months |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients older than 13 years of age
- Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter.
- History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month.
- Normal sense of pain, without anesthesia or paresthesia.
- Willingness to participate and sign the informed consent.
Key exclusion criteria (4 listed)
- 1- Concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions.
- 2- Pregnancy and lactation. 3- Ulcers as a manifestation of systemic disorders such as Ulcerative Colitis, Crohn's disease, Behçet's syndrome or serious anemia.
- 4- Treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry.
- 5- Treatment of the current ulcer with any topical or systemic medication. 6- Attendance of any other clinical trials prior to 3 months of study entry.
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 |
|---|---|---|
| omega-3Also: fish oilpolyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months | Drug | experimental |
| placeboAlso: isopropylmyristate oilsoft gelatinous capsules filled with isopropylmyristate oil | Drug | isopropylmyristate oil |
Primary outcome
quality of life
Time frame: six months
Measurement of oral health related quality of life (OHR-QoL),this parameter was carried out at baseline, and at 6 months of the study using the Arabic version of oral health impact profile-14 (OHIP-14) questionnaire.
3 secondary outcomes
Pain associated with the ulcers
Time frame: Six months
Duration of ulcers episode
Time frame: Six months
The monthly number of ulcer outbreaks
Time frame: Monthly for six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
- Background: PubMed 23481688Hjorth E, Zhu M, Toro VC, Vedin I, Palmblad J, Cederholm T, Freund-Levi Y, Faxen-Irving G, Wahlund LO, Basun H, Eriksdotter M, Schultzberg M. Omega-3 fatty acids enhance phagocytosis of Alzheimer's disease-related amyloid-beta42 by human microglia and decrease inflammatory markers. J Alzheimers Dis. 2013;35(4):697-713. doi: 10.3233/JAD-130131.
- alzheimersLink provided by the sponsor.
Related trials for Recurrent Mouth Ulcers
Recruiting
The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa
Recurrent Aphthous Stomatitis, Mouth Ulcer
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.
Amr M Elkhouli, ass prof principal investigator
October 6 University
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 omega-3 in people with Recurrent Mouth Ulcers, run by October 6 University at 1 site in Egypt.
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 5 inclusion and 4 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 15 Apr 2013. 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 Egypt. 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.
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?
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?
quality of life (time frame: six months). 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 NCT01831453, 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 15 Apr 2013; AzTrials last refreshed its copy on 8 Nov 2026.