Exploration of the Transfer of Barium From Thermal Mud (T2BT)

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.

Study Overview

• Status: Unknown
• Conditions: Mud Therapy
• Intervention / Treatment: Other: Mud therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dax, France, 40100
    • Recruiting
    • Institut du Thermalisme
    • Contact: Karine Dubourg, PhD; Phone Number: 05.58.56.89.94; Email: karine.dubourg@u-bordeaux.fr
    • Principal Investigator: Frédéric Bauduer, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single arm; Healthy volunteers	Other: Mud therapy; Application of sludge poultice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the plasma level of barium	Plasma level of barium	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the urinary rate of barium	Urinary rate of barium	3 weeks
Plasma level of barium exceeds the level deemed tolerable by INRS (French Institute for Research and Security)	plasma levels of barium	3 weeks
Number of patients who doubles the urinary and plasma level of barium	plasma and urinary levels of barium	3 weeks

Collaborators and Investigators

• Sponsor: Association Francaise pour la Recherche Thermale
• Investigators: Principal Investigator: Frédéric Bauduer, Pr, Institut du Thermalisme

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2020
• Primary Completion (ANTICIPATED): July 30, 2020
• Study Completion (ANTICIPATED): September 30, 2020

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: mud therapy; natural mineral water; barium; poultices; skin transfer
• Other Study ID Numbers: 2019-A01614-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No