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Mud TherapyT2BTNCT04111653

Exploration of the Transfer of Barium From Thermal Mud

A study testing Mud therapy in people with Mud Therapy, run by Association Francaise pour la Recherche Thermale at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It involves conducting a clinical study on a population of healthy volunteers (age between 18 and 30 years) without direct benefit for the subject to explore a transfer of barium in the blood and urine following applications of thermal mud. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Mud Therapy
What is being tested?
Mud therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteFrance
Study dates
13 Jan 2020to 30 Sep 2020
Phase
Interventional
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 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • volunteers, healthy (without known and / or treated disease)
  • 18 to 30 years old,
  • men and women, who can give their informed consent, presenting the elements of cutaneous and general tolerance of sludge applications
  • patient affiliated to a social security scheme

Who cannot join

  • subject who can not give informed consent
  • pregnant woman ; woman of childbearing years not wishing to have contraception available for the duration of the trial
  • subject to a legal protection measure or a judicial review, subject having a known allergy to a heavy metal, a BMI greater than 30
  • a characterized contact eczema, an active dermatosis, an acute affection, a disorder of the cutaneous sensitivity, an intolerance to the heat
  • heart, kidney or lung disease that may be decompensated with the use of hot products
  • a progressive disease (inflammatory, infectious or tumoral) potentially liable to worsen with the application of thermal physical agents

Trial locations and contacts

1 site in 1 country.

Jerome Dimet, PhD contact

5.58.05.29.30 ext. 33

jerome.dimet@ght40.fr

Anne-Hélène Boivin contact

5.58.05.29.09 ext. 33

anne-helene.boivin@ght40.fr

France1 site, 1 recruiting

  • Institut du Thermalisme

    Dax, 40100

    Karine Dubourg, PhD, 05.58.56.89.94, karine.dubourg@u-bordeaux.fr

    Frédéric Bauduer, Pr

    Recruiting

Other trials in France

About this study

Official title: Exploration of the Transfer of Barium From Thermal Mud (T2BT Study)

It involves conducting a clinical study on a population of healthy volunteers (age between 18 and 30 years) without direct benefit for the subject to explore a transfer of barium in the blood and urine following applications of thermal mud. The main objective is to highlight an increase in serum barium level of at least twice.

Read the detailed description

The presence of barium in thermal clays was noted by the ARS (french administration) who interviewed the Directorate General of Health (DGS); the latter seized the National Academy of Medicine (June 2016) which reported in February 2017.

In this report it was stated that there was no argument in favor of toxic phenomena related to the presence of barium but that it was appropriate, in particular, to evaluate a possible passage of barium in the skin in subjects who are treated with thermal mud

  • by observing, where appropriate, an increase in serum and urinary barium levels in the subjects concerned and
  • by measuring a possible depletion of barium in the sludge used. The DGS validated the various recommendations of the Academy and asked, in January 2018, the National Council of Thermal Establishments (CNETH) to implement the recommendations of the Academy.

It will therefore be a prospective before-after interventional study, implementing 15 daily applications of 6 mud poultices made with a clay used as thermal clay and containing appreciable barium levels.

A surveillance will be put in place with the event of suspected event, the volunteer can then be seen by a doctor.

Conditions
Mud Therapy
Being tested
Mud therapy
Keywords
mud therapy, natural mineral water, barium, poultices, skin transfer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mud therapyOther

    Application of sludge poultice

Study groups in NCT04111653
Study groupRoleWhat they receive
Single armExperimentalHealthy volunteers
Receives: Other: Mud therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of the plasma level of barium

    Plasma level of barium

    Measured: 3 weeks

Secondary outcomes (3)

  1. Measurement of the urinary rate of barium

    Urinary rate of barium

    Measured: 3 weeks

  2. Plasma level of barium exceeds the level deemed tolerable by INRS (French Institute for Research and Security)

    plasma levels of barium

    Measured: 3 weeks

  3. Number of patients who doubles the urinary and plasma level of barium

    plasma and urinary levels of barium

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start13 Jan 2020
  3. Primary completion30 Jul 2020 (estimated)
  4. Study completion30 Sep 2020 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04111653
Sponsor's protocol ID
2019-A01614-53
Acronym
T2BT
Status last verified
Jul 2020
First submitted
30 Sep 2019
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roques CF, Trèves R, Queneau P, Bontoux D. Avis de l'académie nationale de médecine relatif à l'évaluation des risques sanitaires liés à la présence de baryum dans des argiles constitutives des boues thermales et à l'absence de contrôle sanitaire des boues thermales. Bull Acad Ntle Méd., , 201: 13-38, 2017.

  • Ainouche R, Tabone W, Bouvier CE, Renaud V. Usage thérapeutique (des boues thermales), panorama du thermalisme français en 2013. Bulletin de l'AFTH (Association Française des Techniques Hydrothermales), 2014, n° 25, Symposium Utilisation des boues en établissement thermal, Enghien les Bains, Novembre 2013, pp. 7-11

  • Gomes C, Carretero MI, Pozo M, Maraver F, Cantista P et al. Peloids and pelotherapy : historical evolution, classification and glossary. Applied clay science 75-76:28-38, 2013.

  • Liu H, Zeng C, Gao SG, Yang T, Luo W, Li YS, Xiong YL, Sun JP, Lei GH. The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2013 Oct;41(5):1418-25. doi: 10.1177/0300060513488509. Epub 2013 Sep 5.

    PubMed 24008567

  • Roques CF. Mud Therapy. Data of clinical evidence. Balnea 10:57-62, 2015.

  • Xiang J, Wu D, Li J. Clinical Efficacy of Mudpack Therapy in Treating Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Studies. Am J Phys Med Rehabil. 2016 Feb;95(2):121-31. doi: 10.1097/PHM.0000000000000354.

    PubMed 26203645

  • Roques CF, Queneau P. [SPA therapy for pain of patients with chronic low back pain, knee osteo-arthritis and fibromyalgia]. Bull Acad Natl Med. 2016 Mar;200(3):575-86; discussion 586-7. French.

    PubMed 28644605

  • World Health Organization (WHO) - 2001 - IPCS (International Programme on Chemical Safety) - Concise international chemical assessment document 33 - barium and barium compounds. 57 pp

  • Conseil canadien des Ministres de l'environnement - Recommandations canadiennes pour la qualité des sols - environnement et santé humaine. Le baryum. Feuillet d'information 2013, 1 doc 11 pp

  • Kravchenko J, Darrah TH, Miller RK, Lyerly HK, Vengosh A. A review of the health impacts of barium from natural and anthropogenic exposure. Environ Geochem Health. 2014 Aug;36(4):797-814. doi: 10.1007/s10653-014-9622-7. Epub 2014 May 21.

    PubMed 24844320

  • INRS - base de données de fiches toxicologiques. Baryum et composés. Fiche toxicologique complète n°125. 1 doc 12 pp, 2012

  • Ding C, Pan Y, Zhang A, Zhu C, Liu D, Xu G, Zheng Y, Yan H. [Distribution of rubidium, cesium, beryllium, strontium, and barium in blood and urine in general Chinese population]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2015 Dec;33(12):894-9. doi: 10.3760/cma.j.issn.1001-9391.2015.12.004. Chinese.

    PubMed 27122328

Questions about this trial

What is this clinical trial studying?

A study testing Mud therapy in people with Mud Therapy, run by Association Francaise pour la Recherche Thermale at 1 site 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 4 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 9 Jul 2020. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jerome Dimet, PhD (5.58.05.29.30 ext. 33, jerome.dimet@ght40.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the plasma level of barium (time frame: 3 weeks). 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 NCT04111653, which also lists 12 linked publications.

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 9 Jul 2020.

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