Digestive System Surgical ProceduresPOLYAMALNCT04219956
Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery
A study testing Polyamine Deficient Diet in people with Digestive System Surgical Procedures, run by Nantes University Hospital at 4 sites in France.
Trial summary
The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Surgical Procedures
- What is being tested?
- Polyamine Deficient Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 4 sitesFrance
- Study dates
- 3 Feb 2020to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years)
- Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity
- Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids
- Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications)
- Written informed consent form obtained from the patient
- Affiliated to the social security
Who cannot join
- Pregnant women
- Minor, adult under guardianship or benefiting from a legal protection
- Oncological surgery
- Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)
- Drug addicts patients, or under opiate dependency
- Chronic pain patients (pain over 3 months)
Show all 14Show fewer
- Patients in nursing home or convalescence home (diet non possible in institution)
- Planned hospitalisation before the intervention (during the 7 days before the surgery)
- Severe undernutrition defined by the HAS criteria (weight loss > 10% in 1 month and/or > 15% in 6 months, albumin at inclusion <15g/l)
- Patient refusing the possibility to change his eating habits
- Oral feeding impossible preoperatively
- Patient not able to express himself on their pain (silent, …)
- Decompensated psychiatric pathologies (severe depression syndrome,…)
- Patient unable to understand the protocol and/or to give his informed consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHRU Brest La Cavale Blanche
Brest
Jérémie Thereaux, MD PhD
- Recruiting
Hôpital Louis Mourier from Ap-HP
Colombes, 92700
David MOSZKOWICZ, Pr, david.moszkowicz@aphp.fr
- Recruiting
CHD Vendée
La Roche-sur-Yon
Emeric Abet
- Recruiting
CHU Nantes Hôtel Dieu
Nantes
Blanchard Claire, MD PhD
Tristan Greilsamer, MD
About this study
Official title: A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.
The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.
Read the detailed description
Morphine derivatives are known to be a major cause of postoperative ileus and also operative hyperalgesia. Operative hyperalgesia corresponds to an increase in morphine needs postoperatively which is proportional to the morphine dose necessary during the surgery. This effect is due to two mechanisms: opioids tolerance and induced hypersensitivity.
N-methyl-D-aspartate receptors (R-NMDA) play a key role in this induced hypersensitivity. Polyamines, organic compounds with several amines functions, are known R-NMDA agonists. They increase the phosphorylation of the tyrosine group within the NR2B subunit responsible for the inflammatory hyperalgesia.
Limiting the binding of polyamines to the R-NMDA seems an easy, safe and efficient way to limit the hypersensitivity induced post-operatively.
Most of the polyamines in the human body come from food. One study listed food regarding their polyamines content and allowed to check the safety of a polyamine deficient diet. Such a well-followed diet would allow to reduce by 20 the polyamines quantity present in the body.
The aim of this study is to evaluate whether a deficient polyamine diet introduced 7 days before and continued up to 7 days after an abdominal surgery requiring the use of morphine post-operatively reduces the post-operative pain, the consumption of analgesics (morphine) post-operatively and improve the recovery ability. Abdominals surgeries concerned will be the eventration cure and digestive continuity.
The medico-economic impact will be observed during this study.
- Conditions
- Digestive System Surgical Procedures
- Being tested
- Polyamine Deficient Diet
- Keywords
- Abdominal surgery, Polyamine, Postoperative pain, Morphine, Hypersensitivity
- Medical subject headings
- Pain, Postoperative, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyamine Deficient DietOther
Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet
| Study group | Role | What they receive |
|---|---|---|
| Polyamine deficient diet | Experimental | Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet Receives: Other: Polyamine Deficient Diet |
| Control | No intervention | Usual Diet plus two snacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group measured every 6 hours in resting position, upon return from the operative room
Measured: 72 hours post-surgery
Secondary outcomes (10)
Change in the analgesics consumption post-operatively
Measure of the analgesics consumption by the nurse during hospitalisation and by the patient with the patient book up to 15 days postsurgery
Measured: 15 days post-surgery
Change in the main dimension of pain
Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI)
Measured: 6 months post-surgery
Change of the recovery time of the gas transit
Evaluation of the time to recover the gas transit post-surgery (in days)
Measured: 6 months post-surgery
Change of duration of urinary catheterization
Recovery of spontaneous urination post-surgery (in days)
Measured: 6 months post-surgery
Change in the delay before the first postoperative lift
Time before walking post-surgery (in days)
Measured: 6 months post-surgery
Change in length of hospitalisation stay and sick leave
Hospitalisation time and sick leave (in days)
Measured: 6 months post-surgery
Change in neuropathic pain: Neuropathic pain scale (DN4)
Use of the Neuropathic pain scale for patients seen for their postsurgery pain or complications. The scale contains 10 questions, the range is between 0-10, 10 being the worst score.
Measured: 6 months post-surgery
Change in global health status
Use of autoquestionnaire EuroQol-5 Dimension (EQ-5D) to evaluate the global health status of the patients. The scale contains two parts, the first one contains 5 items to be completed by the patients with 5 levels for each item, the worst score being 55555. The second part is an analog visual scale with a range between 0-100, 0 being the worst score.
Measured: 1 month before surgery, 1 month and 6 months post-surgery
Change of the recovery ability
Evaluation of the recovery ability using the Quality of Recovery-15 Questionnaire (QoR-15)
Measured: 1 month before surgery, 1 month and 6 months post-surgery
Change in the quality of life
Assessment of the patient's quality of life by using the Short-Form Health Survey 36 questionnaire (SF-36)
Measured: 1 month before surgery, 1 month and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start3 Feb 2020
- Primary completionApr 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine Ouest (CRNH)
- Responsible party
- Sponsor
- Investigators
- Claire Blanchard, MD-PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219956
- Sponsor's protocol ID
- RC19_0023
- Acronym
- POLYAMAL
- Status last verified
- Nov 2025
- First submitted
- 3 Jan 2020
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT04219956
- Acronym / sponsor ID
- POLYAMAL / RC19_0023
- Conditions
- Digestive System Surgical Procedures
- Keywords
- Abdominal surgery, Polyamine, Postoperative pain, Morphine, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine Ouest (CRNH)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Jan 2020 (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.
The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.
Detailed description
Morphine derivatives are known to be a major cause of postoperative ileus and also operative hyperalgesia. Operative hyperalgesia corresponds to an increase in morphine needs postoperatively which is proportional to the morphine dose necessary during the surgery. This effect is due to two mechanisms: opioids tolerance and induced hypersensitivity.
N-methyl-D-aspartate receptors (R-NMDA) play a key role in this induced hypersensitivity. Polyamines, organic compounds with several amines functions, are known R-NMDA agonists. They increase the phosphorylation of the tyrosine group within the NR2B subunit responsible for the inflammatory hyperalgesia.
Limiting the binding of polyamines to the R-NMDA seems an easy, safe and efficient way to limit the hypersensitivity induced post-operatively.
Most of the polyamines in the human body come from food. One study listed food regarding their polyamines content and allowed to check the safety of a polyamine deficient diet. Such a well-followed diet would allow to reduce by 20 the polyamines quantity present in the body.
The aim of this study is to evaluate whether a deficient polyamine diet introduced 7 days before and continued up to 7 days after an abdominal surgery requiring the use of morphine post-operatively reduces the post-operative pain, the consumption of analgesics (morphine) post-operatively and improve the recovery ability. Abdominals surgeries concerned will be the eventration cure and digestive continuity.
The medico-economic impact will be observed during this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyamine deficient diet | Experimental | Other: Polyamine Deficient DietDiet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet |
| Control | No intervention | –Usual Diet plus two snacks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (>18 years)
- Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity
- Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids
- Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications)
- Written informed consent form obtained from the patient
Key exclusion criteria (14 listed)
- Pregnant women
- Minor, adult under guardianship or benefiting from a legal protection
- Oncological surgery
- Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)
- Drug addicts patients, or under opiate dependency
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 |
|---|---|---|
| Polyamine Deficient DietDiet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet | Other | Polyamine deficient diet |
Primary outcome
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group
Time frame: 72 hours post-surgery
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group measured every 6 hours in resting position, upon return from the operative room
10 secondary outcomes
Change in the analgesics consumption post-operatively
Time frame: 15 days post-surgery
Change in the main dimension of pain
Time frame: 6 months post-surgery
Change of the recovery time of the gas transit
Time frame: 6 months post-surgery
Change of duration of urinary catheterization
Time frame: 6 months post-surgery
Change in the delay before the first postoperative lift
Time frame: 6 months post-surgery
Change in length of hospitalisation stay and sick leave
Time frame: 6 months post-surgery
Change in neuropathic pain: Neuropathic pain scale (DN4)
Time frame: 6 months post-surgery
Change in global health status
Time frame: 1 month before surgery, 1 month and 6 months post-surgery
Change of the recovery ability
Time frame: 1 month before surgery, 1 month and 6 months post-surgery
Change in the quality of life
Time frame: 1 month before surgery, 1 month and 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
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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.
Claire Blanchard, MD-PhD principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyamine Deficient Diet in people with Digestive System Surgical Procedures, run by Nantes University Hospital at 4 sites in France.
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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Blanchard, MD-PhD (+33 (0)2 40 08 30 22, claire.blanchard@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group (time frame: 72 hours post-surgery). 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 14 Nov 2025.