Geraniol treatment of irritable bowel syndrome patients
| ISRCTN | ISRCTN47041881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47041881 |
| Secondary identifying numbers | IBS-22-05 |
- Submission date
- 09/07/2018
- Registration date
- 19/07/2018
- Last edited
- 23/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Irritable bowel syndrome (IBS) is a disease that can cause bloating, diarrhoea, constipation and intestinal discomfort. It can also lead to dysbiosis, which is where there is a disturbance or imbalance in the microbes that live in the gut (gut microbiota), along with inflammation of the intestines. There is not yet an effective way to treat IBS.
Essential oils, which are natural oils that come from plants, are considered to be antibacterial and anti-inflammatory, and are known to have an effect on gut microbiota. Geraniol is a compound that comes from essential oils from plants such as lemongrass and rose, and has been shown to have strong anti-inflammatory properties. Additionally, geraniol has been shown to be effective against colitis (a symptom of IBD) and dysbiosis in studies on mice.
As geraniol is safe for humans, we aimed to determine whether geraniol was effective at reducing inflammation and dysbiosis in patients with IBD.
Who can participate?
Patients with IBS aged 18-65, weighing between 48 and 104 kg with a BMI of less than 27.
What does the study involve?
Participants will be asked to take capsules of geraniol orally daily for 4 weeks (geraniol dose depends on body weight) and will be asked to provide fecal samples before treatment, after 4 weeks of treatment and 4 weeks after treatment has ended.
What are the possible benefits and risks of participating?
The possible benefit to participants of taking part is that previous studies have shown that similar treatments that affect gut microbiota lead to improvement of IBD symptoms such as bloating and diarrhoea; therefore, this may also be the case for geraniol treatment. There are no known risks to participants of taking part.
Where is the study run from?
1. Inflammatory Bowel Disease Unit, S. Orsola-Malpighi Hospital, Bologna, Italy (lead centre)
2. Spedali Civili di Brescia, Brescia, Italy (satellite centre)
When is the study starting and how long is it expected to run for?
January 2015 to December 2017
Who is funding the study?
1. University of Bologna (Italy)
2. Xeda International SA (France)
Who is the main contact?
Professor Enzo Spisni
enzo.spisni@unibo.it
Contact information
Scientific
Via Selmi 3
Bologna
40126
Italy
 ORCID ID |
0000-0002-8525-2981 |
|---|
Study information
| Study design | Interventional open label non-randomised multi-centre pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN47041881_PIS.docx |
| Scientific title | Effect of dietary geraniol on intestinal dysbiosis in irritable bowel syndrome patients |
| Study acronym | IBS-Ge-OH |
| Study objectives | Geraniol could be a food supplement with anti-inflammatory and anti-dysbiotic activity in irritable bowel syndrome (IBS) patients. |
| Ethics approval(s) | Ethics Committee of the AOU Policlinico S. Orsola-Malpighi, 29/10/2013, CE code 100/2013/U/Sper Ethics Committee of the ASST Spedali Civili di Brescia, 03/06/2015, CE code NP2047 |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome (IBS) |
| Intervention | Participants underwent geraniol treatment for a period of 4 weeks and was taken daily at a maximum dose of 8 mg/Kg/day. Geraniol was provided in capsules containing 150 mg geraniol and 160 mg soy lecithin. The number of capsules given was calculated depending on the body weight of partcipants. 1. Participants weighing 48-59 kg were given a dose of 3 capsules per day 2. Participants weighing 60-74 kg were given a dose of 4 capsules per day 3. Participants weighing 75-89 kg were given a dose of 5 capsules per day 4. Participants weighing 90-104 kg were given a dose of 6 capsules per day. After taking geraniol daily for 4 weeks, there was 4 weeks of follow up - a 'wash out' period where geraniol was not taken. Participants were asked to provide fecal samples before treatment, after 4 weeks of treatment and 4 weeks after treatment was complete. |
| Intervention type | Supplement |
| Primary outcome measure | Changes in fecal microbiota composition after 4 weeks of geraniol administration was measured through phylogenetic DNA array analysis of fecal samples before starting geraniol treatment (visit 1), after 4 weeks of treatment (visit 2) and 4 weeks after treatment finished (visit 3, after 4 weeks of wash out). |
| Secondary outcome measures | 1. Fecal microbial composition in patients with IBS was measured using phylogenetic DNA array analysis of fecal samples before starting geraniol treatment (visit 1). 2. Changes in the microbiota-immune system axis was measured through Luminex analysis of plasma for the levels of cytokines and chemokines involved in the T helper 17 pathway (IL-1β, IL-4, IL-6, IL-10, IL-17A, IL-17F, IL-21, IL-22, IL-23, IL-25, IL-31, IL-33, IFN-γ, sCD40L, TNF-α). This was measured before starting geraniol treatment (visit 1), after 4 weeks of treatment (visit 2) and 4 weeks after treatment finished (visit 3). |
| Overall study start date | 01/01/2015 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1) Signature of informed consent 2) Irritable bowel syndrome, meeting the Roma III criteria for diagnosis of IBS 3) Body weight between 46 kg and 100 kg, with BMI less than 27 4) Aged 18-65 years |
| Key exclusion criteria | 1. Taken steroid anti-inflammatory drugs, antibiotics or supplements and/or functional foods containing probiotics or prebiotics in the months prior to enrolment 2. Pregnancy, suspected pregnancy or breastfeeding 3. Diagnosed with IBD 4. Coeliac disease 5. Severe systemic disease 6. Lactose intolerant 7. Known food allergies 8. Known or suspected hypersensitivity to geraniol or soy 9. Serious concomitant diseases that contraindicate participation in the study (in the opinion of the investigator) 10. Use of experimental drugs in the 2 months prior to enrolment |
| Date of first enrolment | 01/03/2015 |
| Date of final enrolment | 30/10/2017 |
Locations
Countries of recruitment
- Italy
Study participating centres
Bologna
40126
Italy
Brescia
25123
Italy
Sponsor information
University/education
Via Selmi 3
Bologna
40126
Italy
| Website | http://www.unibo.it/en/homepage |
|---|---|
"ROR" |
https://ror.org/01111rn36 |
Industry
Route nationale 7 - ZAC LA CRAU -
SAINT ANDIOL
13670
France
| Website | https://www.xeda.com/ |
|---|
Funders
Funder type
Not defined
Government organisation / Local government
- Alternative name(s)
- University of Bologna, UNIBO
- Location
- Italy
Results and Publications
| Intention to publish date | 01/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We intend to publish in BMC Complementary and Alternative Medicine. |
| IPD sharing plan | Data was collected in pseudonymous form and explicit consent to provide raw data to third parties not involved in the clinical trial was not given by the patients. The explicit consent was given only to publish data in an aggregate form. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 02/04/2019 | No | Yes | ||
| Results article | results | 19/12/2018 | 07/11/2019 | Yes | No |
| Results article | 10/10/2022 | 23/08/2023 | Yes | No |
Additional files
- ISRCTN47041881_PIS.docx
- Uploaded 02/04/2019
Editorial Notes
23/08/2023: Publication reference added.
23/11/2020: Internal review.
07/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
24/05/2019: Internal review.
02/04/2019: The participant information sheet has been uploaded.
